Comparison of the Pregnancy Outcomes in Patients With the Polycystic Ovarian Syndrome in Two Endometrial Preparation Method GnRH Agonist Plus Hormone Replacement Therapy Versus Hormone Replacement Therapy in Frozen Embryo Transfer Cycle
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Chemical pregnancy
研究概览
简要总结
The study is conducted at Arash Women's Hospital on all women undergoing the frozen embryo transfer cycle. Patients who signed informed consent will be randomly divided into two groups. The first group will receive GnRH agonist plus hormone replacement therapy for endometrial preparation. Group 2 will receive hormone replacement therapy. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments are placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure is explained to her and informed consent is obtained. Then the treatment is performed based on the kind of treatment in the envelope.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years
排除标准
- •Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage
研究组 & 干预措施
HRT
HRT protocol : estradiol and progesterone
干预措施: HRT (Drug)
Long GnRH agonist + HRT
Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone
干预措施: Long GnRH agonist + HRT (Drug)
结局指标
主要结局
Chemical pregnancy
时间窗: 14 days after transfer
A positive beta hCG levels
Clinical pregnancy
时间窗: 12 weeks of pregnancy
The gestational sac will be observed by Ultrasonography
Endometrial thickness
时间窗: On the day of transfer
Endometrial thickness on the day of transfer will be measured by transvaginal ultrasound
次要结局
未报告次要终点