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Reproductive System Cleanse Again Scarring and Adhesions

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  • Journal List
  • MedGenMed
  • five.6(2); 2004
  • PMC1395760

MedGenMed. 2004; 6(two): 51.

Published online 2004 Jun 21.

Treating Female Infertility and Improving IVF Pregnancy Rates With a Manual Concrete Therapy Technique*

C. Richard Rex, MD, Marvin A Heuer, Medico, Eugenia Due south Scharf, PhD, and Jonathan J Shuster, PhD

C. Richard Male monarch, Florida Medical and Research Institute, P.A., Gainesville, Florida;

C. Richard King

Florida Medical and Research Institute, P.A., Gainesville, Florida

Marvin A Heuer

College of Medicine, University of Florida, Gainesville, and Iovate Health Sciences Services, Inc. Toronto, Ontario

Eugenia Southward Scharf

medical writer/researcher, Gainesville, Florida

Jonathan J Shuster

Dept. of Statistics, College of Medicine, University of Florida, Gainesville

Abstract

Context

Infertility and pregnancy.

Objective

To assess the effectiveness of site-specific manual soft tissue therapy in (1) facilitating natural fertility and (2) improving in vitro fertilization (IVF) pregnancy rates in women with histories indicating abdominopelvic adhesion formation.

Design and Intervention

Pursuant to 2 promising pilot studies, 53 infertile, premenopausal patients received a 10- to 20-hour series of site-specific manual physical therapy treatments. Seventeen patients hoped to attain a natural pregnancy; 36 planned to undergo IVF within xv months. The primary criteria for inclusion in the studies were the inability to conceive post-obit a minimum of 12 months of unprotected intercourse and suspected or confirmed pelvic adhesions due to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), or trauma. Treatments were specifically designed to address biomechanical dysfunctions of the pelvis, sacrum, and coccyx and restricted soft tissue and visceral mobility due to adhesions or microadhesions affecting the reproductive organs and side by side structures.

Main Issue Measures

(1) Natural fertility group: pregnancy inside one yr of therapy and subsequent full-term commitment; (2) Pre-IVF group: pregnancy (via transfer of fresh embryos from nondonor eggs) within xv months of the last manual treatment engagement.

Results

Natural Fertility Grouping

Of the xiv patients available for follow-upwards (ages 25 to 44; mean, 33.5 years), 10 (71.4%) became pregnant within 1 year, and 9 (64.3%) reported total-term deliveries. Three of the nine women who delivered reported a subsequent pregnancy, suggesting that the treatment protocol might have lasting effects. Two women have had a second alive nascency commitment; and the 3rd is yet pregnant.

Pre-IVF group

Of the 25 patients available for follow-up (ages 28 to 44; mean, 36 years), clinical pregnancies were documented in 22 of 33 embryo transfers vs the United states of america Centers for Disease Control and Prevention (CDC) 2001 historic period-adjusted expected number of 12.7 (P < .001). The estimated odds ratio for a successful pregnancy in a bike (manual handling: no treatment) is iii.20 (95% confidence interval = 1.55–8.4).

Conclusions

The data trend across these studies suggests that this innovative site-specific protocol of manual soft-tissue therapy facilitates fertility in women with a wide array of adhesion-related infertility and biomechanical reproductive organ dysfunction. The therapy, designed to improve function by restoring visceral, osseous, and soft-tissue mobility, is a nonsurgical, noninvasive manual technique with no risks and few, if any, agin side effects or complications. As such, it should exist considered a new adjunct to existing medical infertility treatments.

Introduction

The purpose of the present serial of investigations was to assess the effectiveness of site-specific manual soft-tissue therapy in treating infertility in women with a history indicating probable abdominopelvic adhesion formation, eg, prior surgery, endometriosis, infection, inflammatory procedure, trauma, or tubal obstacle.

Adhesions and Infertility

In the U.s., infertility is defined as the inability to conceive after 12 months of unprotected sexual intercourse.[ane,2] Internationally, the time frame is more often than not longer — 24 months.[3] Infertility is a common problem affecting 10% to 15% of heterosexual couples. Estimates suggest that 40% of the issues are attributable to the female person, twoscore% to the male, 20% to both or unknown, and that some 25% of infertile couples accept > 1 factor impeding fertility.[3] Equally nearly infertility enquiry lacks control couples for comparison, much of the infertility literature is anecdotal.[four]

Of the approximately five 1000000 infertile women in the United States, it is estimated that 2 1000000 (forty%) take medical or hormonal infertility; 1 million (20%) have idiopathic infertility; and 2 million (40%) have mechanical infertility.[5]

Pelvic adhesions are oftentimes cited amid the primary causes of mechanical infertility.[4,6] Adhesions are deposits of fibrous tissue that form as a natural inflammatory response to tissue harm after surgery, infection, inflammation, or trauma. They form equally a by-product of the healing procedure and may remain long after the original site of inflammation or trauma has healed. They may adhere to a specific organ or muscle, either within the myofascial construction of the organ, on its surface, or every bit an attachment to neighboring structures. Wherever they occur, adhesions distort the anatomy and cause decreased mobility and part.[4]

In addition to being a common outcome of pelvic surgery, the formation of pelvic adhesions is known to accompany related conditions such as endometriosis, pelvic inflammatory affliction (PID), tubal obstruction, polyps, pelvic spasms, bowel obstruction, and chronic abdominopelvic pain.[6–8] Information technology is presumed that some of these dysfunctions cause, or are caused by, adhesions. Moreover, a certain proportion of idiopathic infertility may be due to microadhesions that have formed in the pelvis as the body healed from a previous inflammation or trauma. Microadhesions are frequently besides pocket-size to come across, and thus difficult to diagnose.

Effects of Abdominopelvic Adhesions

In sum, adhesions tin can restrict the mobility and function of the organs, ligaments, osseous structures, muscles, fascia, and nerves. Thus, they affect the biomechanics of the entire abdominopelvic region, limiting the ability to conceive even with in vitro fertilization (IVF) and other assisted reproductive technologies (Fine art).

Infertility-causing adhesions may form in the post-obit locations:

  • on uterine walls and ligaments, increasing the possibility of uterine spasm, implantation bug, and miscarriage and decreasing the power to conceive;

  • at and within the tissues of the neck, creating stenosis, affecting the relaxed midline position, contributing to uterine spasms, and complicating sperm transfer to the uterus;

  • on the surface of the ovaries, preventing exposure of the ovum and making transfer to the fallopian tube difficult;

  • at the distal aspect of the fallopian tube, restricting the tentacle-similar grasping of the egg by the fimbria, hence increasing its risk of being wasted in the abdominal crenel; and

  • anywhere on the inside or outside of the fallopian tube, causing partial or total tubal occlusion, decreasing the probability of conception, and increasing the chance of an ectopic pregnancy.[9–11]

Value of Intervention

Clinically, we accept observed that site-specific manual soft-tissue therapy improves soft-tissue mobility, elasticity, and distensibility. Theoretically, mobilization of the soft tissue may break collagenous cantankerous-links and adhesions that crusade pain and dysfunction,[12] including physician-diagnosed mechanical infertility.

In improver to its apparent employ as a natural infertility handling, this therapy functions as an adjunct to regular gynecologic care when practical before intrauterine insemination (IUI) and IVF. Nosotros doubtable that the therapy specifically helps improve mobility and motility of the reproductive organs by decreasing the post-obit:

  • adhesions and microadhesions on and within the uterine walls, helping to create a more than hospitable surface for implantation;

  • uterine and cervical hypertonicity and spasm, thus creating a more relaxed environment for implantation;

  • cervical stenosis, adhesions, and tensions within the neck and its attachments, thus improving cervical mobility and facilitating transfer to the preferred implantation site.

Connective Tissue and Adhesions

The ability of manual therapy to affect connective tissues and adhesions has back up in the basic literature on mechanical tissue testing and connective tissue physiology and remodeling. Specific sustained physical forces applied to a given surface area alter connective tissue length and mobility.[13]

Adhesion formation occurs after soft-tissue trauma and is caused past an inflammatory response to tissue impairment. The body responds to injury by activating macrophages to debride and clean the damaged area. Fibroblasts brainstorm to replace lost collagen, producing a fibrinous exudate. Myofibroblasts then appear, anchor to adjacent collagen fibers, and contract, thus shrinking the tissue.[xiv–17]

As collagenous fibroblasts align inside the structure, collagen is laid downward in a haphazard way, and cross-links begin to grade. The event is the formation of a fibrinous adhesion, which may crusade a subsequent adherence of the adjacent serosal surfaces. Tissue shrinkage leads to dysfunctional move of the area that, in plow, creates more than mechanical irritation, thus perpetuating the cycle.[14–17] These mechanical components have been proposed as the underlying machinery of adhesion-related pain.[eighteen]

As healing fourth dimension increases, cross-links may abound into microadhesions, then adhesions, and somewhen thicken into scars.[15,16] Pocket-size adhesion formations are ofttimes express and may exist captivated within a few days past fibrinolytic mechanisms, only permanent adhesions can course betwixt the peritoneum and the serosal surface of adjacent organs. These permanent adhesions are considered a pathologic state in which the continuous unity of the peritoneal wall or serosal surface of organs is destroyed, leading to harm of their physiologic functions.[19,20] Mobilization of the soft tissues using site-specific manual therapy appears to interruption the attachments of the collagenous cantankerous-links within the adhesions, thus restoring normal mobility and office to the previously adhered organs.

Physical Therapy and Infertility

A search into the use of manual physical therapy as an infertility treatment yielded a series of studies conducted between 1978 and 1989 in the Czech Republic. The Mojzisovà method includes a combination of soft tissue and osseous mobilization techniques, post-isometric relaxation, and a abode practice programme over a 6-calendar month treatment period. Information technology is based on the premise that accidents (including falls) and sedentary lifestyles can crusade blockages or constrictions in the lower spine that lead to pelvic spasms and other functional disturbances of the pelvic region. Thus, co-ordinate to Mojzisovà, "there is a directly human relationship between the condition of the lower back muscles and the mode the reproductive organs function."[21,22]

The purpose of the second Prague study, based on 2006 randomly selected infertile women, was to decide which types of infertility were best suited for treatment past the Mojzisovà method. Results showed that conception rates ranged from a low of xi% for women aged xl to 44 to a high of 46% for the age grouping 20 to 24. Other factors increasing the risk of success included an agile lifestyle and the absenteeism of tubal obstructions and other intrusive conditions, such equally PID, abdominal and/or pelvic surgery, and ectopic pregnancy.[21]

A subsequent study (1987 to 1989) based on the above findings compared the Mojzisovà method with several control treatments. Criteria for participation were equally follows: (1) age betwixt 22 and xxx years; (2) normal quality/quantity of partner'due south sperm; and (iii) patency of fallopian tubes. The study population included 166 women whose mean duration of infertility was iv years; 118 women completed the trial. The mean formulation rate for the principal experimental group was significantly college than that for the three control groups, who either performed "not-genuine" exercises or did non exercise at all - 34.3% (12/35) vs 8.4% (vii/83) (P < .01).[22]

Pilot Studies

Airplane pilot Study #1 (1989 to 1992)

Facilitating fertility through this site-specific soft-tissue therapy originated equally an unplanned upshot of treating physical therapy patients for a diversity of pelvic pain symptoms in areas where decreased tissue mobility was noted. In brief, 4 previously infertile women became pregnant coincidental with their treatment. Two of the women, anile 28 and 42, reported infertility as a issue of bilateral tubal occlusion; they had been trying to excogitate for 7 and ten years, respectively. Their handling protocols had been designed to decrease pain and increase function by breaking adhesive cross-links at specific sites in the abdominal and pelvic regions of the trunk. All 4 pregnancies resulted in full-term deliveries, and 1 adult female reported a subsequent full-term pregnancy and live nascence. Every bit a retrospective review of these cases, documented through clinical ascertainment, patient reports, and gynecologic records, Pilot Report #1 was the first test of the hypothesis that the therapy could facilitate fertility in previously infertile women.[23]

Pilot Study #2 (1995 to 1997)

In a delayed attempt to substantiate the results of Pilot Study #1, a prospective study with 4 new patients was conducted. To test the hypothesis that the therapy could decrease adhesions and therefore improve reproductive organ function, Pilot Written report #two required bilateral tubal occlusion, diagnosed by pre- and posttreatment hysterosalpingogram (HSG), laparoscopy and/or laparotomy. Although two patients showed no change in patency later on treatment, the 3rd patient exhibited i patent tube, and the fourth demonstrated ane patent tube and 1 improved tube.[23]

Figures 1 and ​ 2 depict pretreatment and posttreatment HSGs for a 34-year-old woman with no prior pregnancies who had been infertile for 8 years. She was referred to physical therapy with a history of bilateral occlusion with hydrosalpinx, as diagnosed by chromotubation during laparoscopy and laparotomy. Further support for this diagnosis was provided by ii separate pretreatment HSG studies approximately i year apart. In a posttreatment HSG, 1 tube demonstrated free spillage of dissimilarity dye, and the contralateral tube was improved with increased migration of the dye (ie, the contrast medium filled more of the ampullary portion of the contralateral tube).[23]

An external file that holds a picture, illustration, etc. Object name is art-mgm480429.fig1.jpg

Pretreatment HSG for a 34-year-former woman: bilateral tubal apoplexy with left hydrosalpinx. Diagnosis was consistent with pretreatment laparoscopy and laparotomy.

An external file that holds a picture, illustration, etc. Object name is art-mgm480429.fig2.jpg

Posttreatment HSG: persistent hydrosalpinx with increased migration of the dye in the left tube; free spillage of dissimilarity via the correct tube.

The promising results obtained in Pilot Studies #one and #2 suggested the methodology for the 2 subsequent studies included in this article: I. Facilitating Natural Fertility, and II. Improving IVF Pregnancy Rates.

Studies I and II (1998 to 2003)

Although each study is separately presented beneath, many subject characteristics and the intervention itself are common to both. Patient histories were obtained from medical records and included concrete therapy and biomechanical assessments; gynecologic, surgical and trauma histories; and prior infertility tests, diagnoses, and treatments.

Discipline Option

Presence of Adhesions

The purpose of the two studies was to assess the effectiveness of site-specific transmission soft-tissue therapy in treating biomechanical infertility in women with probable abdominopelvic adhesion germination. Thus, all enrolled subjects had histories of conditions indicating a potent probability of adhesion formation earlier treatment (ie, abdominal and/or pelvic surgery, infectious or inflammatory affliction, or trauma). Moreover, 48.7% of patients had definite diagnoses of "adhesions" affecting the reproductive and/or neighboring structures. Although it seemed unlikely that manual soft-tissue therapy would have a direct event on patients also having medical or hormonal infertility, no patient was excluded from the studies for these weather.

Medical Histories

The relevant medical histories for the subjects in the two studies include the following:

  • Gynecologic: Abdominopelvic pain, abortion, adhered ovaries at fimbriae, adhesions (abdominal, pelvic), bicornuate uterus, bladder infection, C-department, chronic pelvic inflammation, chlamydia, cystitis, D&C, dysmenorrhea, dyspareunia, ectopic pregnancy, endometriosis, failure to ovulate, fibroids, hydatid cyst of Morgagni at tube, hydrosalpinx, interstitial cystitis, irregular menstrual periods, multiple miscarriage, partially blocked and adhered tubes, numbness at C-section scar, ovarian cysts, PID, pelvic scarring, polyps in uterine horn, ruptured cyst, thyroid and hormonal problems, uterine prolapse, tubal apoplexy (unilateral, bilateral), tubal phimosis, urinary incontinence, and vaginitis.

  • Surgical: Abdominal, abortion, appendectomy, bladder repair, C-section, cervical, D&C, episiotomy, fibroidectomy, hysteroscopy, laparoscopy, laparotomy, lysis of adhesions, myomectomy, ovarian cystectomy, pelvic, tuboplasty, and uterine suspension.

  • Trauma: Cleaved basic; falls; injuries to depression back, hip, pelvis, sacrum, and coccyx; car accidents; and physical and sexual corruption.

  • Prior infertility tests and diagnoses: Infertility tests included gynecologic concrete examinations and cultures, FSH and TSH tests, ultrasound, HSG, laparoscopy, and laparotomy. Some patients also had hysteroscopy, endometrial and peritoneal biopsies. Infertility diagnoses included hormonal problems, total bilateral occlusion, unilateral occlusion with contralateral tube partially blocked, and hydrosalpinx.

  • Prior infertility treatments: In addition to HSG, laparotomy, laparoscopy, and hysteroscopy (used primarily for diagnosis), prior infertility treatments included surgery (see above); pharmaceuticals (ie, clomiphene [Clomid] , estradiol, FSH, gonadatropins [Lupron], menotropin [Repronex], micronized progesterone [Prometrium]); and assisted reproductive techniques (ie, IUI and IVF).

The Intervention

The master goals of manual therapy are to decrease pain and restore mobility. The intent of the detail therapy used in this study is to create microfailure of collagenous cross-links, the "building blocks" of adhesions. These unique soft-tissue techniques were adult later on extensive study of electric current, innovative physical therapy methods.

Following a thorough medical, gynecologic, and surgical history, specific sites of visceral cantankerous-linking were deduced as likely adhesion sites. The therapist also employed sufficient palpation and evaluation skills to notation areas of decreased mobility. The restricted soft tissues were engaged and cantankerous-links were perceived to release every bit evidenced by increased mobility at the precise sites of visceral and myofascial restrictions after each therapy session.

Later a perceived increase in histologic length (presumably due to deformation of collagenous cantankerous-links), the soft tissues were noted to get more pliable, with increased mobility and flexibility. These changes were further demonstrated past improved alignment, biomechanics, and increased range of move of osseous and soft-tissue structures. Many patients reported a decrease in pain symptoms, presumably as a upshot of decreased pressure level on nerves and pain-sensitive structures.

In accord with the standards of the American Physical Therapy Association, detailed clinical records were kept of each patient'due south visit, including treatment dates and duration, symptomatic complaints, areas treated, and handling techniques performed.[24] Depending on the patient's schedule and geographic location, the frequency and duration of treatment ranged from a 1-hr session at weekly or longer intervals to intensive sessions of two to 4 hours of handling daily, performed over 5 days. The standard length of the therapy sessions was 1 to 2 hours, minus 15 minutes for room preparation and paperwork.

Report I. Treating Female Infertility With a Manual Physical Therapy Technique

Subjects

Selection

The main criteria for inclusion in this prospective study were (1) the inability to conceive following at least 12 months of unprotected intercourse, and (2) suspected or confirmed pelvic adhesions attributed to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), miscarriage, or trauma inside the abdominopelvic area. A total of 17 women were selected to receive a series of site-specific manual physical therapy treatments; 3 were lost to follow-upward.

Gynecologic History

All fourteen patients in this study had proven or clinically well-supported suspicion of adhesions. Medical diagnoses included:

Infectious/inflammatory affliction (13) 92.eight%
Abdominopelvic trauma (12) 85.vii%
Abdominopelvic surgery (11) 78.6%
Endometriosis (7) 50.0%
Confirmed pelvic adhesions (5) 35.seven%
Pelvic inflammatory disease (two) 14.three%

Characteristics

Report participants were a multiethnic, primarily white group, ranging in age from 25 to 44 years. The mean age was 33.5 (median, 32); and elapsing of infertility ranged from 1 to xx years, with a mean of iv.9 (median, four) years.

Procedures/Intervention

Largely on the basis of standard physical therapy practices, completion of a minimum of xx handling hours (or pregnancy during the course of therapy) was 1 of the few criteria for inclusion in the written report.[24] None of the patients received concurrent infertility therapies during the treatment catamenia.

Data Drove

Report patients were evaluated and treated between May 1998 and February 2002 and tracked for at least 1 year following therapy. This does not imply that failure to become pregnant within a twelvemonth was deemed permanent infertility,[4] but in terms of facilitating fertility in a timely manner, i year sufficed for outcome assessment. Patients who became pregnant during treatment were tracked through expected commitment appointment. Follow-up information were obtained via questionnaires, telephone calls, letters, and email.

The last data set includes 14 patients who completed the recommended 20 hours of therapy or else became pregnant earlier completing therapy. Three patients were omitted because they did not respond to follow-up attempts.

Results

For purposes of evaluating the effectiveness of site-specific manual soft-tissue therapy in facilitating fertility in women with a history indicating likely abdominopelvic adhesion formation, positive clinical outcomes were defined as (i) natural pregnancy within 1 year of the last treatment date, and (ii) subsequent total-term delivery.

The elapsing of therapy was i to 24 weeks; median hours of therapy, 11. Of the 10 subjects who became pregnant, 9 conceived before receiving the full twenty hours of therapy. Having achieved their objective (pregnancy), continued treatment was accounted unnecessary.

Equally shown in Tabular array 1, 10 of the 14 study participants (71.iv%) demonstrated posttreatment pregnancy, and 9 of xiv (64.3%) subsequently delivered a full-term babe. Hence, ninety% (9/10) of the women who conceived had a live birth delivery, including iii patients who had reported unilateral or bilateral tubal occlusion. The i "unsuccessful" patient (age 32) lost her babe at 28 weeks gestation considering of umbilical cord strangulation.

Table i

Pregnancies and Full-term Births

N # Pregnant # Delivered % Pregnant % Delivered
14 10 ix® 71.iv 64.3

Various studies over the decades take unequivocally demonstrated the statistically significant turn down in female fertility with age. Indeed, as ane expert claims, "a adult female's 35th birthday marks a watershed that irreversibly lowers the probability of reproduction in her life."[4] The 1987 – 1989 Mojzisovà study (see to a higher place) pointedly excluded subjects older than 30 years of age.[22] In view of the import of this factor, Table 2 shows the rate of pregnancy past age range in the current report. Of the patients in the 31 to 45 age range, 63.6% (7/xi) conceived compared with 100% (3/3) patients in the 25 to thirty age range.

Table two

Pregnancies by Age Range

Historic period Range # of Subjects # of Pregnancies % Pregnant
25–30 3 3 100.0
31–45® 11 7 63.6
Total 14 ten 71.4

As historic period 35 is considered the "watershed" for reproductive probability, Table 3 shows the pregnancy and live birth delivery rates obtained by patients in the younger than 35 and 35+ age groups. Of the 9 patients in the < 35 group, 77.viii% (7/9) conceived and 66.vii% (6/9) delivered, equally compared with the lx% (3/5) pregnancy and live birth delivery rates of patients in the 35+ age group.

Table iii

Pregnancies/Deliveries by Age Group

Age Grouping # of Subjects % Pregnant (n) % Delivered (n)
Below 35 9 77.87 (7) 66.seven (half dozen)
35+ 5 threescore.0 (3) 60.0 (3)
Total 14 71.iv (ten) 64.3 (9)

Treatment Condom

None of the patients in the written report reported any observable complications or adverse side furnishings as a upshot of their handling. Indeed, whereas all fourteen patients presented with hurting at their initial evaluation, xiii of the 14 reported decreased pain during or later treatment.

Discussion

Approximately 40% of cases of female infertility are biomechanical and attributable to scarring and/or pelvic adhesions resulting from previous intestinal/pelvic surgery, endometriosis, abdominopelvic infection, inflammatory disease, postinfection tubal damage, ruptured appendix, ruptured ovarian cysts, bowel disease, or foreign torso reaction. Clinically, women with known pelvic adhesions and chronic pelvic pain take responded well to this transmission physical therapy.

Related Research

Although our results tin exist compared with those of the Mojzisovà study (1987–1989), the inclusion criteria differed markedly; ie, nigh of our patients were > thirty years of historic period, and four reported tubal apoplexy. Women with these characteristics were specifically excluded from the Mojzisovà report. Moreover, we purposely sought to treat women with other factors known to decrease the chance of positive results, ie, hormone problems, PID, abdominal and/or pelvic surgery, and ectopic pregnancy. However, the mean conception rate for the study group was 71.4% vs 34.3% for the grouping treated by the Mojzisovà method.[22]

Current and Future Inquiry

On the ground of the encouraging results (come across in a higher place), a number of future studies in facilitating natural fertility are planned. One of these, a virtual replication of the nowadays study, volition employ a much larger sample of infertile women, with subjects randomized into experimental (handling) and control (no-treatment and/or pseudo-treatment) groups.

Every bit Pilot Report #two suggested, this therapy seemed capable of assisting women with occluded fallopian tubes. The present study supported this finding in that three of the 4 patients who reported tubal apoplexy had live births post-obit therapy, including i woman who had been diagnosed (by laparoscopy) with total bilateral occlusion. The therapy as well appears efficacious for some women who have had no success with traditional infertility treatments solitary, including fertility drugs, IUI, IVF, and other assisted reproduction techniques. Separate investigations in these related areas are now beingness conducted.

Some other area of hereafter investigation is the long-term duration of positive furnishings. In Study I, iii patients who delivered following therapy reported a subsequent pregnancy: ii women have had a second alive nativity, and the 3rd is still significant. In time, information technology might also be possible to analyze positive outcomes in relation to factors such as specific dysfunctions, pain complaints and resolution, previous miscarriages, primary and secondary infertility, duration of infertility, blazon and number of prior infertility therapies, prior surgeries, and the optimal number of therapy hours for individual patients.

Lastly, there are strong indications of the efficacy of this therapy as a pre-IVF adjunct, every bit shown in Study II.

Study 2. Improving IVF Pregnancy Rates With a Manual Physical Therapy Technique

Several of our patients who had been receiving the treatment for abdominopelvic pain announced their intention to undergo IVF considering they were unable (for various diagnosed causes) to achieve a natural pregnancy. Thus, in 1998, we began investigating the efficacy of site-specific soft-tissue therapy equally an adjunct to ART for women with suspected or diagnosed pelvic adhesions.

Introduction

In the United States alone, the number of live birth deliveries per year resulting from all ART procedures has risen exponentially from 5600 in 1991,[25] to 14,573 in 1996, to 29,344 in 2001.[26] Of the 29,344 live nascency deliveries, 21,813[27] were through the utilise of the woman's own (nondonor) fresh eggs or embryos, which accounts for 75.2% of all ART procedures.[28] [Note: A live nascency delivery may include multiple babies.[26]]

For those unfamiliar with the procedure, the typical ART wheel using fresh nondonor eggs or embryos includes iv prepregnancy steps. The cycle starts when the adult female begins taking drugs to stimulate ovulation. If successful, the next step is egg retrieval. The eggs are combined with sperm and a few days after fertilization (if successful), selected embryo(southward) are transferred into the uterus. This process is known as IVF and represents 99% of ART procedures.[27,29]

A sobering fact is that the 21,813 alive births using fresh nondonor eggs represent merely 27% of Fine art cycles started (80,864); 31.4% of egg retrievals (69,515); and 33.4% of embryo transfers (65,363).[27,30]

For Art data collection purposes, pregnancy is defined equally a clinical rather than a chemical pregnancy.[31] Although a chemical pregnancy (positive pregnancy test) can be detected by a positive human chorionic gonadotropin within 5 days, a clinical pregnancy is one that has progressed to the stage where the gestational sac and fetal heart motion tin exist documented by ultrasound.[25,31]

Given that only 33.iv% of embryo transfers upshot in a live birth, it is non surprising that a priori pregnancy success rates, expressed as pregnancy per wheel, retrieval, or transfer, are also disappointingly depression. The 26,550 clinical pregnancies obtained by ART cycles using fresh nondonor eggs or embryos in 2001 represent 32.eight% of the total Fine art cycles started (80,864); 38.two% of egg retrievals (69,515); and 40.6% of embryo transfers (65,363).[27,29]

Although other factors (ie, indication, number of transferred embryos) are involved, the historic period of the female is the primary determinant of IVF success at every stage of the ART process: the prognosis for women older than age twoscore is considerably poorer than those who are younger.[25] For women in the 5 historic period groups, < 35; 35–37; 38–40; 41–42, and > 42, the calculated 2001 national rates of pregnancies per embryo transfer are, respectively: 48%; 42%; 34%; 24%; and 12%.[32] The respective rates for live births per transfer are: 41%; 35%; 25%; fourteen%; and 6%.[29, 32]

Since alive births per embryo transfer accept been steadily improving (from 28% in 1996 to 33.four% in 2001),[33] an intervention that increases the frequency of clinical pregnancy rates, particularly in the older historic period groups, would automatically increase the frequency of live-nativity deliveries.

Subjects

Selection

Equally in Study I, the primary criteria for inclusion in this prospective study were the disability to excogitate post-obit at least 12 months of unprotected intercourse and suspected or confirmed pelvic adhesions due to abdominal and/or pelvic surgery, infectious or inflammatory illness (eg, endometriosis, PID), miscarriage, or trauma within the abdominopelvic expanse. Other criteria were the following:

  • intention to undergo IVF therapy within 15 months of the last (manual physical therapy) treatment date;

  • determination to utilize fresh nondonor (own) embryos;

  • power to progress to the embryo transfer phase of the ART procedure (run into footnote).

Betwixt September 1998 and January 2003, a full of 36 women received an individualized series of site-specific manual physical therapy treatments. Of these, eleven patients were ultimately omitted from the present study for the following reasons: 3 used frozen nondonor eggs; 2 used donor eggs; two did non progress to the embryo transfer stage (i woman conceived naturally before and so); and 4 others were lost to follow-up, leaving a total of 25 patients.

Gynecologic History

All 25 patients in this study had proven or clinically well-supported suspicion of adhesions. Medical diagnoses included:

Infectious/inflammatory disease (23) 92.0%
Abdominopelvic surgery (21) 84.0%
Abdominopelvic trauma (14) 56.0%
Confirmed pelvic adhesions (14) 56.0%
Endometriosis (9) 36.0%
Pelvic inflammatory illness (2) 8.0%

Before treatment, xiv/25 patients reported a total of 21 prior natural pregnancies, only 4 of which resulted in a live birth. 20 patients had a total of 78 prior Art attempts, including 54 IUIs. The full number of prior ART pregnancies was 3; 2 of these ended in miscarriage. Thus, before receiving the therapeutic intervention, in that location was only 1 prior Fine art total-term pregnancy in 78 attempts.

Characteristics

The 25 report participants comprised a multiethnic, primarily white, group, ranging in age from 28 to 44 years. At the time of embryo transfer, the hateful historic period was 36 (median, 35.iv), and the hateful duration of infertility was 4.6 years (median, 3.5).

Procedures/Intervention

A total of 23/25 (92.0%) patients received the recommended minimum of ten hours of treatment. [Annotation: Every bit of Jan 2001, x hours was the required minimum.] None of the patients received concurrent infertility therapies during the treatment period.

Information Drove

Study patients were evaluated and treated between September 1998 and Jan 2003. Approximately 1 yr later on their last handling date, patients were contacted to determine whether they had: (one) undergone the embryo transfer phase of IVF therapy, and (ii) used fresh nondonor eggs/embryos (vs frozen or donor eggs).

The final information set includes 25 patients who underwent >/=one IVF transfers within a maximum of fifteen months following handling, using fresh nondonor eggs/embryos. Patients who progressed from embryo transfer to pregnancy were tracked to anticipated commitment date, when possible.

In lieu of asking patients to serve as a control group for this as yet unproven adjunctive therapy, the decision was made to compare the study results with the vast, preexisting control groups represented by the 2001 Assisted Reproductive Engineering science Success Rates: National Summary and Fertility Dispensary Reports, released by the Centers for Illness Control and Prevention (CDC) and the American Society for Reproductive Medicine (December 2003).[26] The command grouping data set was extrapolated from the various figures in this written report.

Past law, the CDC reports its ART success rates by treatment cycles started each year, rather than per patient. In accord with this convention, women who have started >/= 2 cycles per year are represented more than once. Eight of the 25 women in the present study had 2 cycles each, for a total of 33 cycles. CDC success rates, in all age groups using fresh nondonor eggs/embryos, are somewhat (not significantly) lower for women who underwent a previously unsuccessful ART cycle.[34]

The CDC too reports its National Summary by historic period groups. Although other factors (eg, infertility cause, number of embryos transferred) should be considered, a woman's age (when using her own eggs) is the primary determinant of success at every stage of the IVF process.[25] Thus, nosotros did not effort to assess the furnishings of factors other than age in this study.

Statistical Methods

The master outcome measure—pregnancy/transfer charge per unit (as well equally the live birth/transfer rate)—was compared with the CDC 2001 rates (adjusted for age), equally follows. For each attempt, the expected rate is the probability of pregnancy and live birth, respectively, for a woman of the identical age in years. CDC written report Figure 13 (and its accompanying text)[32] provides these data. There is no fabric divergence in success rates between an unsuccessful first attempt and subsequent ART attempts for the aforementioned woman.[34] Because of the pocket-size sample sizes, large sample approximations for the Mantel-Haenszel statistic[35] were thought to be unreliable, and 10,000 simulations were used to obtain the 2-sided P value.

Odds ratios were estimated past the post-obit formula, with N = Sample Size, OBS = Observed Full, and EXP = Expected Total based on the CDC 2001 data:

Estimated Odds Ratio = OBS(N-EXP)/[(N-OBS)EXP]

A 95% confidence interval for the odds ratio was obtained via x,000 simulations, finding the odds ratios that make the P value .025 and .975.

Results

To assess the effectiveness of this site-specific manual soft-tissue therapy in improving pregnancy rates in women undergoing subsequent IVF, the main outcome measure was clinical pregnancy via the transfer of fresh embryos from nondonor eggs, within 15 months of the terminal (manual) treatment engagement.

As discussed above, this study included only those patients who had progressed beyond the early on stages (egg product/retrieval and fertilization) of the ART wheel to the embryo transfer stage, and had used fresh nondonor eggs/embryos. Accordingly, the study results are compared with the 81% (n = 65,353) of the CDC cycles that reached the embryo transfer stage. These numbers were extrapolated from various figures in the 2001 report.[27,29,32,33]

As shown in Table 4, for pregnancies, based on 33 transfers, there were 22 successes. The CDC age-adapted expected rate was 12.7 successes; and the standard error in the observed charge per unit is 2.7 (P < .001).

Table 4

Observed vs Expected Pregnancies

Age Transfers Pregnancies
Observed CDC 2001 Rate Expected
< 35 fifteen 11 (73%) 47.7% seven.15
35–37 half dozen 4 (67%) 42.0% 2.52
38–40 5 3 (60%) 33.eight% one.69
41–42 4 iii (75%) 23.6% 0.94
<42 iii ane (33%) 12.1% 0.36
Total 33 22 12.7

The estimated age-standardized pregnancy odds ratio of manual treatment pre-IVF to no pretreatment is iii.20 (95% confidence interval i.55–viii.4). As an example, if the odds of success for a control handling is i:two vs the odds of success for an experimental treatment of 2:one, the odds ratio is two.0/0.v = 4.0. Annotation that equivalence corresponds to an odds ratio of one.00, which is excluded from the pregnancy interval but not from the live nascency interval (below).

The CDC pregnancy rates per age group ranged from 12% (historic period > 42) to 48% (age < 35). In comparison, the pre-IVF report pregnancy rates ranged from a low of 33% (historic period > 42) to more than 70% (age < 35).

Speaking in terms of actual patients, rather than embryo transfers, clinical pregnancies were documented in 19 of 25 women. The mean number of treatment hours was 17.ane. At that place was no meaningful difference in treatment time between those who progressed from transfer to pregnancy (hateful, 16.9 hours) and those who did non (mean, 17.5 hours).

Although the main outcome measure of this study was pregnancy within 15 months of the last (manual) treatment date, 15 of 33 transfers accept resulted in alive births or continuing pregnancies. Every bit seen in Tabular array 5, the CDC age-adjusted expected number was 10.iii, and the standard error for the observed rate was 2.6 (P = .065). Similarly, it can be estimated that the age-standardized successful live birth odds ratio of manual treatment pre-IVF to no treatment is 1.86 (95% confidence interval 0.86–4.three).

Tabular array 5

Observed vs Expected Live Births

Age Transfers Pregnancies
Observed CDC 2001 Charge per unit Expected
< 35 fifteen 9 (lx%) 41.i% vi.16
35–37 half dozen 2 (33%) 35.1% two.eleven
38–40 five one (20%) 25.4% 1.27
41–42 iv 2 (twenty%) 14.5% 0.58
>42 3 1 (33%) 6.1% 0.18
Total 33 15 ten.3

The confidence interval indicates that plausible outcomes range from a clinically insignificant disadvantage to a clinically important advantage for this pre-IVF treatment over common medical practice in terms of alive births. Again, speaking in terms of actual patients, rather than embryo transfers, xv/25 women have already delivered (due north = 13) or are nonetheless pregnant (northward = 2).

Treatment Safety.

None of the patients in the study reported any observable complications or adverse side furnishings equally a result of their treatment; and all but i patient who presented with pain at the initial evaluation reported decreased pain during or after treatment.

Discussion

Although nosotros can infer that the entire confidence interval for the pregnancy odds ratio is clinically meaning, the confidence interval for live births contains both clinically insignificant values (eg, near 1.0), besides as clinically meaning values. However, the conviction interval for the odds ratio demonstrates the potential for anything from a slightly lower rate to a much college charge per unit. As can be seen in Table 4 and Table 5, the results were particularly encouraging for women > 40 years of historic period. Thus, farther research with a larger sample is needed to define the successful live birth conviction interval more precisely.

Nevertheless, considering national alive births/transfer rates take been steadily improving (from 28.0% in 1996 to 33.four% in 2001),[33] an intervention that manifestly increases clinical pregnancy rates should increase live nascence delivery rates for patients undergoing IVF embryo transfers.

Related Research

In terms of the efficacy of alternative therapies as pre-IVF aids, there is ane published, randomized controlled trial of the effect of acupuncture on the pregnancy rate of women undergoing IVF or intracytoplasmic sperm injection. The 160 patients (mean age, 32.v) in this German language study were randomly assigned to the acupuncture or control group. The main result measure out was clinical pregnancy. Analysis showed that the boilerplate pregnancy rate for the acupuncture group was 42.5% (34/80) vs 26.3% (21/80) for the control group (P = .03).[36] Investigators have concluded that further studies are warranted.[37,38] The acupuncture results tin can be compared with the average 66.seven% (22/33) pregnancy charge per unit obtained in the present study, which used the [much higher] 2001 CDC boilerplate pregnancy/transfer rate of forty.6% as the command group (P < .001). [Besides see Future research, below.]

Future Enquiry

As with Study I, the encouraging results warrant the replication of Study Two, using a considerably larger sample of women (peculiarly in the age 35+ groups) randomized into experimental (treatment) and control (no treatment) groups. A 2d control group, composed of infertile women defective strong indications of adhesion germination, would permit testing the hypothesis that this specific therapy might likewise benefit infertile women without adhesions, eg, past improving apportionment in the pelvic region. The results of this arm of the study could be compared with acupuncture, which seems to work (in part) by increasing blood menstruation to the uterus.[37]

Determination

The information trend beyond the airplane pilot and present studies seems to support the hypothesis that this distinctive protocol of site-specific manual soft-tissue therapy facilitates fertility in women with a broad array of adhesion-related biomechanical dysfunctions. The major indication for its employ is a history suggesting abdominopelvic adhesions (ie, prior surgery, infection, inflammation, or trauma at the reproductive organs or neighboring structures).

This innovative, noninvasive, nonsurgical, manual therapeutic technique confers little risk and few agin side effects or complications, and appears to be an effective treatment for facilitating natural fertility and improving pregnancy rates/embryo transfer in women undergoing subsequent IVF. Thus, information technology tin can be prescribed as an alternative or complementary treatment to standard gynecologic intendance and should exist considered every bit a new adjunct to existing medical infertility treatments.*

Acknowledgments

We would like to thank Thom Fifty. Tyler, MD, PhD, Gainesville, FL and Michael Davidson, DC (United kingdom) for encouraging us in this endeavor. We also give thanks Gerald Wiechmann, PhD (erstwhile Sr. Health Research Advisor, NIH); Cynthia Hodgson, PT, PhD; Sandra Shevlin, DP; and Kimberley Hornberger, PTA for research, writing, and editorial assistance. Lastly, we acknowledge the crucial contributions of Amy B. Hough, our meticulous research assistant.

Notes

Annotation

*As this therapy was directed toward (female) mechanical infertility and would take no event on male factor nor any predictable effects on female person medical/hormonal infertility (ie, diminished ovarian reserve, ovulatory dysfunction), the patients in this study were limited to those who reached the embryo transfer stage of the Fine art cycle. That is, they had progressed beyond the egg production, egg retrieval, and fertilization steps. Fresh, nondonor eggs/embryos were preferred not only by our patients but are used in approximately 75% of all ART cycles.[28]

Footnotes

*Wurn Technique®, patent pending

Contributor Information

C. Richard King, Florida Medical and Enquiry Establish, P.A., Gainesville, Florida.

Marvin A Heuer, Higher of Medicine, University of Florida, Gainesville, and Iovate Health Sciences Services, Inc. Toronto, Ontario.

Eugenia S Scharf, medical writer/researcher, Gainesville, Florida.

Jonathan J Shuster, Dept. of Statistics, College of Medicine, University of Florida, Gainesville.

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