Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis: Randomised Prospective Study.

Not yet recruiting

Conditions: Endometriosis
adenomyosis

Registration Number: 2024-519126-20-00

Lead Sponsor: Hospital Foch

Brief Summary: To assess the impact of the administration of a long-acting GnRH agonist prior to frozen embryo transfer (FET) on clinical pregnancy rates within an assisted reproductive technology (ART) protocol, in patients with endometriosis and/or adenomyosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Female

Target Recruitment: 180

Inclusion Criteria

Women aged 18 to 36 with endometriosis and/or adenomyosis

Having undergone IVF/ICSI with freeze-all, and for whom a blastocyst FET is planned

A normal uterine cavity

An MRI with contrast injection confirming endometriosis and/or adenomyosis during the inclusion visit (MRI performed after patient selection if no results from the past 6 months are available or interpretable)

Having signed a consent form

Affiliated with a health insurance plan

Exclusion Criteria

BMI > 35

Pregnancy and breast

History of implantation failures (≥2)

Endometrial abnormalities

Known uni or bilateral hydrosalpinx

Known hypersensitivity to GnRH, GnRH analogues, or any excipients in DECAPEPTYL® LP, 11.25 mg

Known hypersensitivity to estradiol/progesterone/acetylsalicylic acid/folic acid/cefixime/levofloxacin

Known or suspected breast cancer, or history of breast cancer

Known or suspected cancer of the reproductive system, or history of reproductive system cancer

Known or suspected estrogen-dependent malignant tumors

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary evaluation criterion is the clinical pregnancy rate (confirmed by the presence of a fetal heartbeat), which will be assessed in both groups during the ultrasound conducted at the final visit		The primary evaluation criterion is the clinical pregnancy rate (confirmed by the presence of a fetal heartbeat), which will be assessed in both groups during the ultrasound conducted at the final visit

Secondary Outcome Measures

Name	Time	Method
Number of successful implantations per number of embryos transferred;		Number of successful implantations per number of embryos transferred;
Miscarriage defined as a spontaneous pregnancy loss after a successful implantation;		Miscarriage defined as a spontaneous pregnancy loss after a successful implantation;
Incidence and severity of side effects related to hypoestrogenism (e.g., hot flashes, night sweats, decreased libido, mood swings, etc.)		Incidence and severity of side effects related to hypoestrogenism (e.g., hot flashes, night sweats, decreased libido, mood swings, etc.)