Actively Recruiting
Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis: Randomized Prospective Study
Led by Hopital Foch · Updated on 2026-01-16
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether adding one or two doses of a GnRH agonist injection (Decapeptyl 3mg) before frozen embryo transfer can improve pregnancy rates in women with endometriosis and/or adenomyosis. These conditions involve the presence of uterine tissue outside the normal lining or within the muscle layer, leading to pain, infertility, and lower chances of embryo implantation due to inflammation. The study compares the effects of the GnRH agonist combined with the usual hormone replacement therapy against hormone replacement therapy alone. Participants receive either standard hormonal replacement therapy with estrogens and progestins or that therapy plus one or two injections of the GnRH agonist about one month before embryo transfer. The study groups are randomly assigned, and no masking is used. The main focus is on the frozen embryo transfer procedure supported by these hormonal treatments, assessing how the additional GnRH agonist influences outcomes. During the study, participants will be monitored for pregnancy success through ultrasound three months after the embryo transfer, measuring clinical pregnancy rates as the primary outcome. Secondary outcomes include implantation success, miscarriage rates, and any side effects related to the GnRH agonist treatment over 15 months. Women aged 18 to 36 with documented endometriosis or adenomyosis and planning frozen embryo transfer are included, with regular follow-ups to assess the treatments' effects and safety.
CONDITIONS
Brief Title
Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 36 years with endometriosis and/or adenomyosis
- Planned frozen embryo transfer of a blastocyst after in vitro fertilization or intracytoplasmic micro-injection with freeze all
- Normal uterine cavity
- MRI confirmation of endometriosis and/or adenomyosis at inclusion
- Signed informed consent
- Affiliated with a Health Insurance Plan
You will not qualify if you...
- Age under 18 or 36 years and older
- Body mass index over 35
- History of two or more implantation failures
- Endometrial abnormalities such as synechiae, polyps, myomas, hyperplasia, or hematometra
- Known unilateral or bilateral hydrosalpinx
- MRI showing no endometriosis or adenomyosis
- Hypersensitivity to GnRH, GnRH analogues, Decapeptyl 3 mg excipients, estradiol, progesterone, acetylsalicylic acid, NSAIDs, folic acid, cefixime, cephalosporins, levofloxacin, or quinolones
- History of fluoroquinolone-related tendinopathies
- Epilepsy
- Hypersensitivity to MRI contrast agents
- Known or suspected breast, genital tract, or estrogen-dependent malignant cancers
- Undiagnosed genital bleeding
- Untreated endometrial hyperplasia
- History or current venous or arterial thromboembolic events
- Acute or history of liver disease until tests normalize
- Severe kidney failure
- Severe uncontrolled heart failure
- Active gastroduodenal ulcer
- Asthma caused by salicylates or similar NSAIDs
- GnRH agonist Decapeptyl used within 6 months prior to transfer
- Being deprived of liberty or under guardianship
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive 1 or 2 injections of GnRH agonist approximately 1 month before frozen embryo transfer.
1 to 2 visits for injections
Duration - Duration of hormonal replacement therapy until embryo transfer
Participants undergo hormonal replacement therapy for frozen embryo transfer composed of estrogens and progestins.
1 baseline visit and follow-up visits as needed during therapy
Duration - Up to 15 months after treatment
Participants are monitored for clinical pregnancy outcomes and side effects related to treatment.
Periodic visits with ultrasound and clinical assessments, including a visit 3 months after embryo transfer
Trial Site Locations
Total: 1 location
1
Hopital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
E
Elisabeth Hulier-Ammar, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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