Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital Foch
• Treatments: Triptorelin Pamoate

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.