Studying The Effect of Estradiol Pretreatment on Follicular Synchronization and Intracytoplasmic Sperm Injection (ICSI) Outcome in Antagonist Cycles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Serum estradiol and progesterone level on day of hCG .
研究概览
简要总结
Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles
详细描述
Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. Indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. During COH, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. This approach represents a potential and more physiological alternative to GnRH agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized controlled trial that investigated whether E2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during COH. It depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on ICSI outcome.
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
- None
入排标准
- 年龄范围
- 20 Years 至 37 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 20-37 years.
- •Anti-mullerian (AMH) level greater than 1.2 ng/ml.
- •Body mass index between 18 and 29 kg/m
- •Undergoing a first or second ICSI cycles.
排除标准
- •Endometriosis.
- •Uterine disorders such as fibroids and uterine anomalies.
- •Antral follicular counts (AFC) less than
- •Azoospermic males.
研究组 & 干预措施
Group 1
Cases who received estradiol pretreatment then underwent ICSI.
干预措施: Estradiol Valerate 4mg (Drug)
结局指标
主要结局
Serum estradiol and progesterone level on day of hCG .
时间窗: 7-16 days after start of controlled ovarian stimulation.
serum level of estradiol pg/dl and progesterone ng/dl on day of hCG administration
Total number of gonadotropin ampoules used.
时间窗: 7-16 days after start of controlled ovarian stimulation.
number of gonadotropin ampules used from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration
Total number of follicles by U/S on day of hCG.
时间窗: 7-16 days after start of controlled ovarian stimulation.
number of follicles by ultrasound scan on day of hCG administration
Number of good quality embryos.
时间窗: 3 days after oocyte retrieval.
number of grade 1 and grade 2 day 3 embryos
Endometrial thickness on day of hCG.
时间窗: 7-16 days after start of controlled ovarian stimulation.
thickness of endometrium in mm on day of hCG
Days of stimulation.
时间窗: 7-16 days after start of controlled ovarian stimulation.
number of days from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration until day of hCG administration
Number of mature oocytes
时间窗: 36 hours after oocyte retrieval.
number of metaphase II oocytes after denudation
次要结局
- Clinical pregnancy rate(2 weeks after positive pregnancy test)
- Pregnancy rate(14 days after embryo transfer)
