2024-519126-20-00招募中4 期
Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis: Randomised Prospective Study.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
次要结局
- Number of successful implantations per number of embryos transferred;
- 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.)
研究者
PIRTEA Paul
Scientific
Hospital Foch
研究点 (1)
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