Actively Recruiting
Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp
Led by Yale University · Updated on 2025-07-24
297
Participants Needed
5
Research Sites
132 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.
CONDITIONS
Official Title
Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who plan to undergo IVF for infertility treatment
- Age 18 to less than 40 years at egg retrieval or consent
- Endometriosis diagnosis by surgery or pathology within 10 years or ovarian endometrioma >2 cm confirmed on ultrasound twice
- Body mass index (BMI) between 18 and 40 kg/m2
- AMH > 0.5 ng/ml within 12 months of fresh IVF start or at least one good quality blastocyst stored for frozen embryo transfer
- No known uterine cavity abnormalities within 12 months before embryo transfer
- At least one ovary without significant abnormalities other than endometrioma
- Negative test for gonorrhea and chlamydia within 12 months
- Willing and able to follow trial procedures including reporting outcomes after delivery
You will not qualify if you...
- Use of depot GnRH agonists within 6 months before study start (except standard care arm)
- Use of injectable medroxyprogesterone or birth control implants within 6 months before study start (except standard care arm)
- Continuous use of oral progestins within 1 month before study start (except standard care arm)
- Use of aromatase inhibitors, danazol, or hormonal contraceptives within 1 month before study start
- Pregnancy longer than 8 weeks within last 6 months
- Three or more previous unsuccessful IVF/ICSI attempts
- Hydrosalpinx >2 cm, untreated endometrial polyps, or intrauterine adhesions
- Abnormal cervical cytology excluding treated CIN1 or HPV, untreated CIN2 or CIN3
- History of cancer within 5 years except treated skin cancers
- Recent suicidal thoughts within 12 months
- Allergy to study drugs
- Planned pelvic surgery during trial
- Untreated abnormal prolactin or thyroid function
- Medical conditions preventing pregnancy
- History of low-trauma fractures or osteoporosis risk
- Cirrhosis or abnormal liver function tests
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Colorado Department of Obstetrics & Gynecology
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Johns Hopkins, Division of Reproductive Science and Women's Health Research
Baltimore, Maryland, United States, 21205
Actively Recruiting
5
Duke Fertility
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
H
Heping Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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