A Single Arm Observational Study Evaluating NMP SR Oral Tablets for Luteal Phase Support and Pregnancy Outcomes in IVF Cycles Using GnRH Agonist Trigger and Freeze All Strategy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
In IVF with GnRH agonist trigger early luteal phase deficiency requires exogenous progesterone NMP SR 400 mg Natural Micronized Progesterone Sustained Release is an oral formulation offering consistent progesterone release Objective To assess effectiveness and safety of NMP SR 400 mg once daily as luteal phase support Methods Prospective single arm observational study in women 18 to 38 years IVF with agonist trigger freeze all strategy Serum progesterone on Days 5 8 11 14 post OPU endometrial TVS on Days 8 and 11 Pregnancy outcomes followed to delivery Primary Outcome Proportion achieving serum P4 7 to 20 ng per mL Secondary endometrial parameters clinical ongoing pregnancy rates live birth rate adverse events N equals 50 Nirmiti Clinic Pune
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18 to 38 years Undergoing IVF or ICSI with GnRH agonist trigger Freeze all cycle strategy AMH more than equal to 1.2 ng per mL No allergy to progesterone Written informed consent obtained.
排除标准
- •Uncorrected uterine or endometrial abnormality Medications affecting progesterone metabolism Severe hepatic impairment Concurrent interventional trial participation Planned use of another progesterone formulation.
研究者
Dr Kundan V Ingale
Nirmiti Clinic