Progesterone-primed versus conventional antagonist stimulation during the luteal phase in poor ovarian responders undergoing Duo-Stim protocol- a pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
Controlled ovarian stimulation (COS) is a crucial step in the success of an in vitro fertilization-embryo transfer (IVF-ET) cycle. Theoretically, the possibility of increasing the number of the oocytes retrieved per attempt could result in a higher chance of obtaining a reproductively competent embryo, thus improving the cumulative live birth rate. Despite the recent advances in techniques of COS, the estimated prevalence of poor responders, according to the POSEIDON criteria, is around 40%. Several strategies have been proposed, aiming to maximise ovarian response and success in these patients; however, no standard management has been outlined yet. One such strategy is double stimulation or DuoStim, which proposes ongoing stimulation in the luteal phase immediately following egg retrieval after stimulation in the follicular phase of the same menstrual cycle. This is based on the evidence that multiple follicular waves can arise in a single ovarian cycle in humans. There is a definite need to block the LH surges during the luteal phase of stimulation as well which can be materialized using the standard GnRH antagonist or, lately, using Progestins, which also sustain LH suppression. While the use of progestins has been accepted in the follicular phase, with the advantages being oral use, reduced costs, and better acceptability, its use during the luteal phase has not yet been explored. Therefore, the hypothesis that progestin-induced LH suppression shall act similarly to antagonist even in the luteal phase has prompted us to compare oral progestins with the accepted antagonist-based LH suppression in the luteal phase of a DuoStim protocol.
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
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women with defined decreased ovarian reserve before stimulation: Patients meeting any two of the following criteria: Age greater than 35 years, AMH less than 1.2, AFC less than 5 Unexpected poor response ,despite normal ovarian reserves, to ovarian stimulation in previous cycles: Less than 4 oocytes retrieved in previous IVF/ICSI cycles Unexpected suboptimal response, despite normal ovarian reserves, to ovarian stimulation in previous cycles: 4to 9 oocytes retrieved in previous IVF ICSI cycles Willing to participate in the study Women meeting the above-mentioned criteria and having at least two follicles in each ovary between 2-8 mm at the time of ovum pickup after follicular stimulation, will be taken up for subsequent luteal phase stimulation.
排除标准
- •Diagnosed PCOS Severe male factor infertility,requiring surgical sperm retrieval or severe OATS Donor Recipient Cycles BMI less than 19 kg/m2 or greater than 30 kg/m2 Any history of genital tuberculosis Unwilling to participate in the study.
结局指标
主要结局
Number of oocytes retrieved
时间窗: Baseline (On the day of ovum pickup)
Number of Metaphase-II (M-II) oocytes retrieved
时间窗: Baseline (On the day of ovum pickup)
次要结局
- Total dose of gonadotropins required(Duration of controlled ovarian stimulation)
研究者
Neena Malhotra
All India Institute of Medical Sciences, New Delhi
