A Comparative Study Between Fresh and Frozen Embryo Transfer in Cases of Polycystic Ovaries Syndrome (PCOS) Patients Undergoing in Vitro Fertilization (IVF) Treatment for Infertility as Regards Clinical Pregnancy Rate and IVF Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).
详细描述
Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups:
Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer.
Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries.
- •Women ages ≥20 and <40years old.
- •BMI less than
- •Women who have a history of infertility.
- •All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up).
排除标准
- •History of unilateral oophorectomy.
- •Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion.
- •Severe male factor for infertility such as azoospermia.
- •History of repeated ICSI trials failure.
- •Women who are unable to comply with the study procedures.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 35 days after embryo transfer
Transvaginal Ultrasound to detect gestational sac(GS)
次要结局
- Ectopic pregnancy rate(14 days for BHCG , vaginal US 3 weeks after transfer)
- Chemical pregnancy rate(14 days after embryo transfer.)
- Early ovarian hyperstimulation syndrome rate(OHSS rate)(3 days after follicular aspiration)
研究者
Marwa Mohamed Mahmoud Eid
Principal investigator
Cairo University