Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fertilization Proportions
研究概览
简要总结
In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.
详细描述
Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms:
I. The partial suppression of FSH will allow for further recruitment of early antral follicles.
II. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal ultrasound (TVUS), or
- •Cancellation of a prior IVF cycle due to poor ovarian response.
- •Patients will receive an antagonist stimulation protocol for IVF, or IVF with Intracytoplasmic Sperm Injection (ICSI).
排除标准
- •Severe male factor infertility requiring surgical intervention to obtain sperm
- •Major uterine abnormality,
- •Preimplantation genetic diagnostic (PGD) testing,
- •Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles).
研究组 & 干预措施
Delayed Start
Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.
干预措施: Ganirelix acetate (Drug)
Conventional Start
Ovarian stimulation with standard antagonist protocols (no delay).
干预措施: Ganirelix acetate (Drug)
结局指标
主要结局
Fertilization Proportions
时间窗: 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization
Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.
Number of Oocytes Retrieved
时间窗: up to 1 hour after oocytes retrieved
The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted
次要结局
- Pregnancy Rates(2 to 3 weeks following embryo transfer)
- Stages of Oocyte Nuclear Maturation(average of 1 to 2 hours on the Day of Retrieval)
- Number of Mature Follicles(up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes))
- Oocyte Recovery Rate(up to 1 hours after oocyte retrieval)
- Embryo Quality(One hour on day 2 or 3 (following IVF procedure))