Using GnRH agonist to improve pregnancy rates in women with endometriosis or adenomyosis before embryo transfer
Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
This study is testing if giving GnRH agonists to women with endometriosis or adenomyosis before frozen embryo transfer can help improve their chances of getting pregnant.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 36 Years |
| Sex | Female |
| Sponsor | Hopital Foch Academic / other |
| Locations | 1 site (Suresnes) |
| Trial ID | NCT04356664 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of administering GnRH agonists to women with endometriosis and/or adenomyosis prior to frozen embryo transfer. The study compares the outcomes of patients receiving one or two doses of GnRH agonist alongside standard hormonal support against those receiving hormonal support alone. The aim is to reduce pro-inflammatory markers in the endometrium, potentially enhancing implantation rates and improving fertility outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 36 with diagnosed endometriosis or adenomyosis who are preparing for a frozen embryo transfer.
Not a fit: Patients outside the age range of 18 to 36, those with a high BMI, or those with a history of multiple implantation failures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase pregnancy rates in women suffering from endometriosis and adenomyosis undergoing fertility treatments.
How similar studies have performed: Previous studies have indicated that GnRH agonists can positively influence endometrial conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 to 36 years (women ≥18 years to \<36 years) with endometriosis and / or adenomyosis * Having benefited from In vitro fertilisation /intracytoplasmic micro-injection with freeze all and for whom the frozen embryon transfer of a blastocyst is planned * A normal uterine cavity * An MRI showing endometriosis and / or adenomyosis during the inclusion visit * Having signed a consent form * Being affiliated to a Health Insurance Plan. Exclusion Criteria: * Patient aged \<18 years and ≥ 36 years * BMI\> 35 * History of implantation failures (≥ 2) * Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometra * known hydrosalpinx uni or bilateral * MRI showing no endometriosis or adenomyosis * Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of Decapeptyl 3 mg * Known hypersensitivity to estradiol * Known hypersensitivity to progesterone * Known hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs * Known hypersensitivity to folic acid * Known hypersensitivity to cefixime or an antibiotic in the cephalosporin group * Known hypersensitivity to levofloxacin or any other quinolone * History of tendinopathies related to the administration of fluoroquinolones * Epilepsy * Hypersensitivity to contrast agents for MRI * Known or suspected breast cancer or history of breast cancer * Known or suspected genital tract cancer or history of genital cancer * known or suspected estrogen-dependent malignant neoplasms * Undiagnosed genital haemorrhage * Untreated endometrial hyperplasia * History of idiopathic venous thrombo-embolic accident or evolving venous thrombo-embolic event (deep vein thrombosis, pulmonary embolism) * Recent or evolving arterial thromboembolic stroke (eg angina, myocardial infarction) * Acute liver disease or history of liver disease, until hepatic tests are normalized * Severe renal insufficiency * Severe, uncontrolled heart failure * Evolutionary gastroduodenal ulcer * History of asthma caused by the administration of salicylates or substances of similar activity, especially nonsteroidal anti-inflammatory drugs * GnRH Agonist Decapeptyl administered within 6 months prior to transfer * To be deprived of liberty or under guardianship * Pregnancy and breast feeding.
Where this trial is running
Suresnes
- Hopital Foch — Suresnes, France (Recruiting)
Study contacts
- Study coordinator: Elisabeth Hulier-Ammar, Dr
- Email: e.hulier-ammar@hopital-foch.com
- Phone: 0033146251175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.