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Asherman Syndrome involves the formation of scar tissue within the uterus, which can impact reproductive health. Clinical trials explore various treatment evaluations to address uterine scarring and improve outcomes related to fertility and menstrual...

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Found 39 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

Age: 25Years +FEMALE
2 locations
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Actively Recruiting

Female fertility can be affected by several factors including ovarian function, fallopian tube health, the uterine environment, and mental state, with the ovaries and endometrium playing key roles. Common reproductive diseases impacting fertility include ovarian dysfunction, poor ovarian response, intrauterine adhesion, recurrent implantation failure, and thin endometrium. These conditions currently lack effective treatments, and platelet-rich plasma PRP shows promise, prompting further research into its effects and mechanisms. This study evaluates the use of platelet-rich plasma injections delivered via transvaginal or laparoscopic methods for ovarian diseases such as premature ovarian insufficiency and poor ovarian response. For uterine diseases including intrauterine adhesion, thin endometrium, and repeated implantation failure, PRP is administered through intrauterine perfusion or injections under the endometrium. The study focuses on monitoring the safety of PRP treatment up to three months post-enrollment. Participants are female patients aged 18 to 50 years diagnosed with one of the specified reproductive diseases. Their progress will be tracked through assessments of adverse and serious adverse events from enrollment through the three-month treatment period. Researchers will evaluate the safety of PRP injections and collect data to better understand its potential therapeutic effects in reproductive medicine.

Age: 18Years - 50YearsFEMALEPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating patient-reported pain, bleeding, and the efficiency of devices used during intrauterine device IUD insertions. This trial compares a new FDA-approved, atraumatic suction cervical stabilizer called Carevix with the standard single-tooth tenaculum, which is considered more traumatic. The study also looks at provider satisfaction and ease of use for these devices, focusing on differences in pain scores between patients who have never given birth nulliparous and those who have multiparous. Participants will be randomly assigned to receive either the Carevix device or the standard tenaculum during their IUD insertion procedure. Providers will perform the procedures using the assigned device, and participants will complete surveys about their pain experience and satisfaction immediately after the procedure. The study collects additional information on cultural background, previous contraceptive use, and reasons for choosing IUD insertion or anticipating removal. During the trial, participants will be evaluated for pain at several points before the procedure, during cervix grasping and traction, at IUD placement, and five minutes after completion. Providers will assess ease of device use, number of placement attempts, bleeding, and overall satisfaction right after the procedure. Patient satisfaction and bleeding cessation time will also be measured. The study runs from March 2026 to March 2027, with ongoing assessments during and immediately after the IUD insertion.

Age: 18Years +FEMALEPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES compared to conventional abdominal laparoscopy CAL for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect womens sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

Age: 18Years - 70YearsFEMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are investigating the relationship between low plasma mannose binding lectin p-MBL levels and unexplained reproductive failures, including recurrent pregnancy loss RPL and recurrent implantation failure RIF. The study focuses on patients with reproductive difficulties after assisted reproductive technologies ART such as IVF, ICSI, and frozen embryo transfer FET, as well as after spontaneous conception. The goal is to better understand if low p-MBL levels contribute broadly to reproductive challenges in early pregnancy stages. The study observes three groups of women those with three consecutive pregnancy losses after spontaneous conception, three losses after ART treatments, and those who experienced three failed embryo transfers with good-quality embryos but no clinical pregnancy. Blood samples are collected from participants when they are not pregnant or before 9 weeks gestation to measure p-MBL levels, categorizing them as low, very low, or high. Participants undergo assessments including blood sampling to measure p-MBL levels, which are the primary outcomes of interest. Secondary measures include calculating the odds ratios for low p-MBL levels among these groups. The study excludes women outside the age range or with certain uterine or chromosomal conditions. The research aims to clarify p-MBLs role in early pregnancy failure mechanisms, helping future evaluation of reproductive failure cases.

Age: 18Years - 41YearsFEMALE
1 location
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Actively Recruiting

This research aims to understand awareness, knowledge, and help-seeking behaviors related to gynecological problems among women in Hong Kong. It focuses on patients with conditions like PCOS, endometriosis, miscarriage, or infertility, as well as the general public. The study addresses cultural and social factors that may influence womens health behaviors, especially where Western and Chinese values intersect and where health literacy may be limited. Participants include two groups gynecological patients aged 13 to 60 who have used or plan to use medical services for their conditions, and women aged 13 to 60 from the general public recruited online. Both groups will complete questionnaires designed to evaluate their understanding and behaviors regarding gynecological health issues. The study compares these groups to identify differences and barriers in seeking care. During the study, participants will provide information through questionnaires that explore their knowledge and actions related to PCOS, endometriosis, miscarriage, and infertility. Researchers will look at how social and cultural factors affect these behaviors over about one year. The study is observational, with no treatment involved, and aims to inform future strategies to improve womens health outcomes in Hong Kong.

Age: 13Years - 60YearsAll Genders
1 location
C

Actively Recruiting

Healthy Volunteer

This research aims to understand how genes and environmental factors interact to influence the development of diseases. It focuses on pregnant women and their children from birth up to 18 years old, studying key health conditions like overweight and obesity in children. The study collects detailed lifestyle, family, clinical, and imaging data to explore the origins and long-term health impacts beginning in early life. Participants include pregnant women under 13 weeks of gestation living in Shenyang or nearby areas who plan to deliver at Shengjing Hospital. The study tracks biometric changes in fetuses weekly from the thirteenth week of pregnancy until birth, measures newborn weight, and analyzes gene expression in both mothers and their partners. It also monitors non-invasive prenatal testing results and collects biological samples from children and parents. Throughout the study, children are followed up to age 18 with periodic assessments of their intestinal flora, height, weight, and gene expression at multiple ages. Researchers collect various clinical data and biological samples during pregnancy and childhood to evaluate health outcomes. Participation involves ongoing data collection, clinical visits, and sample donations to monitor growth and development over many years.

Age: 18Years +FEMALE
1 location
U

Actively Recruiting

Healthy Volunteer

Researchers are studying autologous bone marrow stem cell mobilization using the drug Plerixafor to treat women with Ashermans Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure. The goal is to evaluate if Plerixafor can restore endometrial function and improve pregnancy implantation rates compared to standard treatments. This early phase 1 study involves women aged 18 to 40 years with specific diagnoses related to these conditions. The study involves a single subcutaneous dose of 20 mg Plerixafor administered the evening before scheduled standard care surgery for participants. Those weighing over 83 kilograms receive a weight-based dose of 0.24 mg per kilogram. Participants are grouped by their condition refractory Ashermans Syndrome, atrophic endometrium with thin lining, or recurrent implantation failure despite multiple embryo transfers. They will be monitored for changes in endometrial thickness and pregnancy outcomes over time. Participants will be asked to avoid NSAIDs two weeks before and 30 days after treatment and to abstain from intercourse for three months following administration. Assessments will include menstrual bleeding patterns, endometrial blood flow, and histology before treatment and at 3 and 6 months after. Researchers will track implantation rates and pregnancy outcomes every three to six months up to 24 months, with ongoing monitoring to evaluate the treatments impact and safety.

Age: 18Years - 40YearsFEMALEEarly Phase 1
1 location
C

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of two different suturing techniques used during cesarean sections on the healing of the uterine scar and the development of isthmocele, a uterine niche. The study involves pregnant women undergoing cesarean delivery regardless of their pregnancy risk. It aims to compare clinical outcomes, ultrasound features, and molecular markers related to uterine scarring and inflammation, investigating whether barbed sutures improve healing compared to conventional smooth sutures. Participants will be randomly assigned to receive either a barbed absorbable monofilament suture or a conventional smooth multifilament absorbable suture for uterine closure after cesarean section. The barbed suture is a size 0 device with unidirectional spikes that do not require knots, while the conventional suture is size 1 polyglactin. Both techniques use a single-layer, endometrium-free repair method. The study includes follow-up assessments at six months and longer-term monitoring of perinatal outcomes in subsequent pregnancies. During the study, participants will be monitored for clinical outcomes and undergo ultrasound examinations to measure the presence and size of isthmocele at six months postpartum. Molecular markers of hypoxia and inflammation within the uterine cavity will be analyzed, along with assessments of uterine scar stiffness and myometrial texture patterns through ultrasound. The study also tracks symptoms related to isthmocele and evaluates risk factors over an average of two years. Perinatal outcomes in following pregnancies are observed for up to four years, with safety and healing closely followed throughout the study period.

Age: 18Years +FEMALEPhase Not Applicable
1 location
S

Actively Recruiting

Ovarian hyperstimulation syndrome OHSS is a serious complication that can occur during controlled ovarian stimulation in stimulated ovarian cycles. It is believed to result from the release of factors like vascular endothelial growth factor, which increase capillary permeability and cause fluid to leak from blood vessels. This leads to blood thickening and complications such as increased risk of blood clots and reduced blood flow to organs. This clinical trial evaluates the effectiveness of cabergoline compared to coasting in reducing the incidence of OHSS in women undergoing ovarian stimulation. The study involves two groups one group will receive cabergoline at a dose of 0.25 mg daily for 8 days starting from the day of HCG trigger, while the other group will undergo coasting, which means temporarily stopping human menopausal gonadotropin injections for 1 to 3 days while continuing agonist treatment until estradiol levels drop to a safer level. The coasting group may also receive cabergoline daily for 8 days in some cases. OHSS will be monitored early on the day of embryo transfer and 7 days after, with late OHSS assessed 14 days after embryo transfer. Participants will be closely monitored for OHSS occurrence and severity over one month. Assessments include hormone level measurements and follicle monitoring. The study uses a randomized, double-blind design to compare the treatments. Women aged 18 to 38 with a high risk of OHSS and specific hormone levels are eligible. Safety is monitored throughout, and the study is sponsored by Tanta University with a planned end date in November 2026.

Age: 20Years - 35YearsFEMALEPhase 2
1 location

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