Benefit of treatment with a GnRH agonist (neurohormone) prior to frozen embryo transfer in patients with endometriosis (endometrial disease) and / or adenomyosis (another form of endometriosis)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 180

Inclusion Criteria

- Women aged 18 to 36 years (women =18 years to <36 years) with endometriosis and / or adenomyosis
- Having benefited from IVF / ICSI with freeze all and for whom the TEC of a blastocyst is planned
- A normal uterine cavity
- An MRI showing endometriosis and / or adenomyosis during the inclusion visit (MRI performed after patient selection)
- Having signed a consent form
- Being affiliated to a Health Insurance Plan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient aged <18 years and = 36 years
- BMI> 35
- History of implantation failures (= 2)
- Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometry
- known hydrosalpinx uni or bilateral
- MRI showing no endometriosis or adenomyosis
- Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of DECAPEPTYL® L.P. 3 mg (see section 6.1 of the SPC in Appendix 2)
- 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
- Porphyria
- GnRH Agonist DECAPEPTYL® L.P. administered within 6 months prior to transfer
- To be deprived of liberty or under guardianship
-Pregnancy and breast feeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of long-acting GnRH agonist administration on clinical pregnancy rate;Secondary Objective: To evaluate the impact of long-acting GnRH agonist administration on: <br>- implantation rate <br>- miscarriage rate.<br> To measure the side effects inherent to the administration of GnRH agonist;Primary end point(s): The primary endpoint is the clinical pregnancy rate (with cardiac activity) assessed in both groups at last visit ultrasound;Timepoint(s) of evaluation of this end point: At study end.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Successful implantation rate on the number of patients included<br>- Rates of miscarriages on the number of patients included<br>- Side effects related to treatment with DECAPEPTYL ® LP, 3 mg (IM);Timepoint(s) of evaluation of this end point: At study end.