TRIPTORELIN for Endometriosis | Adenomyosis

Inclusion criteria

• {"criterion_text":"- Women aged 18 to 36 with endometriosis and/or adenomyosis\n- Having undergone IVF/ICSI with freeze-all, and for whom a blastocyst FET is planned\n- A normal uterine cavity\n- 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)\n- Having signed a consent form\n- Affiliated with a health insurance plan"}

Exclusion criteria

• {"criterion_text":"- BMI > 35\n- Pregnancy and breast\n- History of implantation failures (≥2)\n- Endometrial abnormalities\n- Known uni or bilateral hydrosalpinx\n- Known hypersensitivity to GnRH, GnRH analogues, or any excipients in DECAPEPTYL® LP, 11.25 mg\n- Known hypersensitivity to estradiol/progesterone/acetylsalicylic acid/folic acid/cefixime/levofloxacin\n- Known or suspected breast cancer, or history of breast cancer\n- Known or suspected cancer of the reproductive system, or history of reproductive system cancer\n- Known or suspected estrogen-dependent malignant tumors"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Clinical pregnancy rate confirmed by the presence of a fetal heartbeat as assessed by ultrasound at the final visit."}

Secondary endpoints

• {"endpoint_text":"- Number of successful implantations per number of embryos transferred;","definition_or_measurement_approach":"Count of successful implantations relative to number of embryos transferred."}
• {"endpoint_text":"- Miscarriage defined as a spontaneous pregnancy loss after a successful implantation;","definition_or_measurement_approach":"Miscarriage defined as spontaneous pregnancy loss occurring after a confirmed successful implantation."}
• {"endpoint_text":"- Incidence and severity of side effects related to hypoestrogenism (e.g., hot flashes, night sweats, decreased libido, mood swings, etc.)","definition_or_measurement_approach":"Incidence and severity assessed by recording adverse events related to hypoestrogenism (examples listed in endpoint)."}

France

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

259

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Hospital Foch

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France