To Compare IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Fixed Day 5 Antagonist Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 252
- 试验地点
- 4
- 主要终点
- Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs
研究概览
简要总结
There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 38 years old.
- •Normal Menstrual cycle of 25-35 days.
- •Body Weight 60to90 kg
- •AMH>1.3 - <3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of >5 on menstrual cycle days 2-3,
排除标准
- •History of premature ovulation
- •Azoospermia
- •Endometriosis AFS ¾
- •Endometrioma
- •Known chromosomal abnormalities
研究组 & 干预措施
Group A: - Follicular phase start of ovarian stimulation with Elonva
Patients considered for ovarian stimulation for IVF/ICSI will be informed and a CF will be given on the day of planning for IVF. In group one, the ovarian stimulation protocol would follow a fixed GnRH antagonist protocol with recombinant FSH, Corifolitropin alfa (Elova150 mcg) starting on day 2 of the menstrual cycle.
Group A: Day 2-3 of cycle: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone During stimulation: on day 8 of stimulation: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone on trigger day: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone
Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Oocyte retrieval will be performed 36 hours after human chorionic gonadotropin (hCG5000 or 10000IU, choriomon, IBSA) plus GnRH-a (0.2 or 0.3 mg Gonapeptyl, Ferring) administration under transvaginal ultrasound guidance.
干预措施: Ovarian stimulation with menstruation or after ovulation (Other)
Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG
. In group two, Elona 150mcg is being administered after ovulation confirmation with home LH kits starting to be used around usual ovulation days, and be confirmed in clinic with LH rise, E2 drop and blood P4 more than 1ng/dl one day after LH kit is positive. The probability of spontaneous pregnancy will be ruled out by betaHCG test. In case a spontaneous pregnancy has been confirmed,we will not start the treatment . Furthermore, in case of sustained progesterone rise,repeated hCG tests will be performed throughout the stimulation cycle to monitor whether there is an early pregnancy or not. If so,the treatment will be cancelled/stopped to prevent the potential risks of stimulation medications during an early pregnancy.From stimulation Day 8 onwards, hormonal stimulation will continue with daily dose. The maximum injection dose for continuing treatment after the first 7 days will be 200 IU. (10) Final oocyte maturation will be administered when 3 follicles reach 17mm or more.
干预措施: Ovarian stimulation with menstruation or after ovulation (Other)
结局指标
主要结局
Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
未报告次要终点
研究者
Maryam Farid Mojtahedi
Specialist IVF
ART Fertility Clinics LLC