Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate in both groups at last visit ultrasound
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient aged <18 years and ≥ 36 years
- •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
- •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.
研究组 & 干预措施
Frozen embryo transfer with HRT and GnRH agonist
Patient will received 1 or 2 injection of GnRH agonist priori to usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
干预措施: GnRH agonist (Drug)
Frozen embryo transfer with Hormonal Replacement Therapy (HRT)
Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
结局指标
主要结局
Clinical pregnancy rate in both groups at last visit ultrasound
时间窗: 3 months after frozen embryon transfer
Clinical pregnancy will be defined by any cardiac activity detected during the ultrasound performed at the last visit.
次要结局
- Side effects related to treatment with Decapeptyl 3 mg(15 months)
- Successful implantation rate on the number of patients included(3 months after frozen embryon transfer)
- Rates of miscarriages on the number of patients included(3 months after frozen embryon transfer)