Oral Elagolix versus Injectable GnRH Antagonist in IVF Freeze-All Cycles: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This prospective randomized open label parallel group non inferiority trial evaluates the efficacy and tolerability of oral Elagolix 150 mg twice daily compared with injectable GnRH antagonists Cetrorelix 0.25 mg or ganirelix 0.25 mg daily for prevention of premature LH surge during controlled ovarian stimulation in IVF freeze all cycles A total of 150 women aged 21 to 38 years undergoing their first IVF cycle with normal ovarian reserve will be randomized in a 1 to 1 ratio The primary endpoint is the incidence of premature LH surge or progesterone rise on trigger day Secondary outcomes include oocyte yield fertilization rate blastocyst formation clinical and ongoing pregnancy rates safety outcomes including OHSS and patient reported treatment satisfaction The study aims to determine whether oral Elagolix is non inferior to injectable GnRH antagonists while improving patient convenience and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 21 to 38 years undergoing their first IVF cycle Normal ovarian reserve AMH more than equal to 1 ng per mL and AFC more than equal to 8 BMI 18 to 30 kg per m² No previous ovarian surgery Signed written informed consent prior to any study specific procedure.
排除标准
- •History of poor ovarian response less than equal to 3 oocytes retrieved in any prior stimulation Known contraindications to GnRH antagonists Known hypersensitivity to Elagolix or any of its excipients Significant hepatic or renal impairment defined as alanine aminotransferase or aspartate aminotransferase more than two times the upper limit of normal, or estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters Concurrent use of medications known to affect bone metabolism example bisphosphonates corticosteroids denosumab Donor oocyte recipients excluded to maintain homogeneity of study population Participation in another clinical trial within 30 days prior to enrollment Positive infectious disease screening HBsAg Anti HCV HIV 1 and 2 VDRL.
研究者
Dr Kundan V Ingale
Nirmiti Clinic