Brief Title
Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
Official Title
Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
Brief Summary
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.
Detailed Description
Endometriosis reveals the presence of glands or endometrial stroma outside the uterus, responsible for pain and infertility. Adenomyosis illustrates an invagination of endometrial islets within the myometrium, leading to a disturbance of its contractile activity, also potentiated by local hyperestrogenism. These two pathologies are often associated, and express an alteration of the eutopic endometrium by pro-inflammatory markers responsible for a lower implantation rate. GnRH agonists are known to decrease these pro-inflammatory markers (cytochrome P450 and Cox 2 aromatase) in the eutopic endometrium of women with endometriosis or adenomyosis. Patients will received 1 or 2 injection of GnRH delay agonist (Decapeptyl 3mg) approximately 1 month before the frozen embryo transfer.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Clinical pregnancy rate in both groups at last visit ultrasound
Secondary Outcome
Successful implantation rate on the number of patients included
Condition
Endometriosis
Intervention
GnRH agonist
Study Arms / Comparison Groups
Frozen embryo transfer with Hormonal Replacement Therapy (HRT)
Description: Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
180
Start Date
March 18, 2021
Completion Date
January 1, 2023
Primary Completion Date
January 1, 2023
Eligibility 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.
Gender
Female
Ages
18 Years - 36 Years
Accepts Healthy Volunteers
No
Contacts
Jean-Marc Ayoubi, Pr, 0033146251175, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04356664
Organization ID
2019_0012
Responsible Party
Sponsor
Study Sponsor
Hopital Foch
Study Sponsor
Jean-Marc Ayoubi, Pr, Principal Investigator, Hopital Foch
Verification Date
August 2022