The Comparative Results of Progestin Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Ovarian Stimulation Methods on IVF Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Blastulation Rate
研究概览
简要总结
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
详细描述
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
Ovarian stimulation will be conducted according to the assigned arm protocol.
Both artificially prepared and modified natural cycles will be eligible to be included and the choice will be done according to the doctor's preference and the patient's menstrual cycle regularity.
- For artificially prepared transfers, Estradiol Hemihydrate (Estrofem©, 2mg, Novo Nordisk, Malov/Denmark) 3x1 PO will be started on the day 2 of the menstrual cycle. After 12-14 days of usage, in order not to cancel the cycle, endometrial thickness needs measured at least 7mm and serum progesterone level < 1.5 ng/mL.
- For luteal support in addition to Progesterone (Progestan Dex©, 25mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 SC once, with a 12-hour interval at day 14 of the menstrual cycle; Progesterone (Progestan©, 200mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 PV will be started and continued for 5 days. Embryo transfer will be performed at 6th day. Estradiol Hemihydrate will be stopped on week 2 and progesterone support will be continued until the 8th week of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI > 18 kg/m2 ve <35 kg/m2
- •Couples that accept being included in the study
- •Couple accepting thawed embryo transfer
排除标准
- •Known chromosomal abnormality in either member of the couple
- •Couples with unexplained infertility
- •BMI > 30 kg/m2
- •Mullerian malformations
- •Undergoing oocyte cryopreservation for medical reasons (such as malignancies)
- •Couple insists on fresh embryo transfer
研究组 & 干预措施
Progestin Primed Ovarian Stimulation (PPOS)
In this patient group, progestin based protocol is going to be the main course of treatment.
干预措施: Progestin (Drug)
GnRH Antagonist Stimulation
In this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment.
干预措施: GnRH antagonist (Drug)
结局指标
主要结局
Blastulation Rate
时间窗: Day 5 or 6 after fertilization
number of blastocysts up to day 6 / the number of fertilized 2PN embryos
次要结局
- Live Birth Rate(9 months)
- PGT Results(14 days after blastocyte culture sampling)
- Chemical Pregnancy(on day 11 after transfer)
- Ongoing pregnancy(on gestational week 12)
研究者
Emre Kar
Principal Investigator
Nesta Clinic