To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on final oocyte maturation in long agonist in vitro fertilisation cycles- A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on total number of M-II oocytes retrieved per follicle.
研究概览
简要总结
Oocyte maturation is a critical process to the success of in vitro fertilization (IVF) treatment, during which the oocyte gains competence for fertilization. One of the most important predictive factors for the success of IVF is the maturity of oocytes along with number and quality of oocytes available for fertilization. In Long Agonist protocol, there is no endogenous hCG due to suppression of Hypothalamic-Pituitary-Ovarian (HPO) axis. Since, final oocyte maturation and quality of oocytes depend on exogenous hCG given, therefore, we want to find the best dose of r-hCG for obtaining the highest number of mature oocytes after stimulation. Women fulfilling the inclusion criteria will be included in the study and they will undergo treatment with standard long gonadotropin‑releasing hormone (GnRH) agonist protocol. Patients will be randomly allocated into either the 250 or 500 µg r‑hCG group according to a computer‑generated randomization. Transvaginal ultrasound‑guided oocyte retrieval will be performed 36 hours after administration of r‑hCG injection. Primary outcome includes total number of M-II oocytes retrieved per follicle and secondary outcomes include number of good quality embryos generated, biochemical pregnancy rate, clinical pregnancy rate, incidence of Ovarian hyperstimulation syndrome (OHSS) and subgroup analysis in poor responder group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •All women between the age group of 21–40 years with normal or poor ovarian reserve undergoing IVF ET by Long Agonist Protocol.
排除标准
- •History of OHSS High basal ovarian reserve (AMH more than 8ng/ml or AFC more than 24) Hyper response (more than 18 follicles of diameter 11mm or more).
结局指标
主要结局
To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on total number of M-II oocytes retrieved per follicle.
时间窗: 38 hours
次要结局
- Number of good quality embryos generated.(4-5 days)
- Biochemical pregnancy rate(2-3 weeks)
- Clinical pregnancy rate(5-6 weeks)
- Incidence of OHSS(7-10 days)
研究者
Dr Aashim Garg
Amrita Institute of Medical Sciences
