Clinical trial NCT04356664: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Endometriosis
Adenomyosis
Infertility, Female
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical pregnancy rate in both groups at last visit ultrasound
timeFrame: 3 months after frozen embryon transfer
Secondary outcomes:
measure: Successful implantation rate on the number of patients included
timeFrame: 3 months after frozen embryon transfer
measure: Rates of miscarriages on the number of patients included
timeFrame: 3 months after frozen embryon transfer
measure: Side effects related to treatment with Decapeptyl 3 mg
timeFrame: 15 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Jean-Marc Ayoubi, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch
name: Paul Pirtea, Dr
role: STUDY_DIRECTOR
References: