Comparison of ART outcome in 0.2 mg GnRH agonist trigger vs 0.3 mg GnRH agonist trigger in Poor ovarian reserve females, a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 654
- 试验地点
- 6
- 主要终点
- Percentage of mature oocytes retrieval
研究概览
简要总结
**Background:**Human chorionic gonadotrophin (HCG) has been successfully used for decades as a surrogate for the natural LH surge for oocyte maturation during IVF cycles. Gonadotrophin releasing hormone agonist as the trigger was introduced for IVF in high responders to minimize the risk of OHSS but with a compromised pregnancy rate because of luteolytic action. The FSH surge in combination with the direct action of GnRH on ovarian receptors may explain the role of the agonist trigger Shapiro et al. demonstrated that acceptable fertilization rates, implantation, clinical pregnancy, ongoing pregnancy, and early pregnancy loss could still be obtained using a dual trigger in a population of high responders. These findings further indicated that GnRH agonist has important roles in oocyte maturation and embryo implantation. Keeping in view the promising result in high and normal responders, we wish to demonstrate the role of dual trigger in poor responders. **Objective:**To explore whether a 0.3 mg triptorelin acetatefor final oocyte maturation could improve oocyte quality and subsequently theIVF outcomes of patients with POR as compare to that of 0.2 mg Triptorelinacetate..**Primary measurable outcome:**2.
Percentage of mature oocytes retrieved: Percentage of mature oocytes retrieved following oocyte retrieval: (Total number of m2 oocytes per 100 retrieved oocytes).Secondary****Measurable outcome: · Follicle oocyte index: The ratio between the number of oocytes collected at the Ovum pick up and the number of antral follicles at the beginning of OS
· Oocyte retrieval rate: number of retrieved oocytes per 100 expected Oocytes from follicles more than 14mm in diameter on the trigger day
· Implantation rate: Number of intrauterine gestational sacs observed by transvaginal ultrasonography per 100 transferred embryos.
· Clinical pregnancy rate: Number of patients with USG suggestive of Foetal Heart Rate at 6 to 7 weeks per 100 Embryo transfer cycle
· Ongoing pregnancy rate: Presence of gestational sacs with a heartbeat at the 12th gestational week.
This is a prospective, open-label, multicenter, randomized, parallel-group study to be conducted in 654 women in the age group of 25 to 40 years (both inclusive), who are indicated to undergo COS as part of ART. Each woman will participate in the study for a maximum duration of approximately 28 weeks after signing the informed consent form (ICF). This will include a screening period, a single cycle of COS and ART procedures, and post-ART follow-up for ongoing pregnancy till 12 completed wks of gestation.
· OHSS occurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Antral follicle count on day 2 of menses <5 2) AMH < 1.2 ng /dl.
排除标准
- •BMI; ≥ 30 kg/m2 2) Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, 3) Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome 4)Previous major uterine surgery 5)Donor oocyte cycle.
- •Gestational carrier 7) Fertility preservation.
- •Adenomyosis 9) Endometriosis 10) Premature ovarian failure.
- •Thin endometrium <6mm after 21 days of HRT (oestradiol valerate).
结局指标
主要结局
Percentage of mature oocytes retrieval
时间窗: on the day of ovum of Pick up
次要结局
- Oocyte retrieval rate(On the day of ovum pick-up)
- Implantation rate(4- 6 weeks after embryo transfer)
- Follicle oocyte index(On the day of ovum pick-up)
- Clinical pregnancy rate(4-6 weeks after embryo transfer)
- Ongoing pregnancy rate(12th week of gestation)
- OHSS occurrence rate(4 weeks from ovum pick up)