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临床试验/NCT02330757
NCT02330757招募中4 期

Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients

Mansoura University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年10月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
150
试验地点
2
主要终点
Clinical pregnancy rate

研究概览

简要总结

Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)

详细描述

Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.

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 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women without PCOS as defined by the Rotterdam criteria.
  • Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).

排除标准

  • PCOS or polycystic ovary on ultrasound scan.
  • Moderate or severe endometriosis.
  • Hydrosalpinx.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.

研究组 & 干预措施

HRT group

Active Comparator

Women will be subjected to HRT using Estradiol valerate before FET

干预措施: Estradiol valerate (Drug)

MOS group

Active Comparator

Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET

干预措施: Sequential Clomiphene citrate and Gonadotropin (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 6 weeks after embryo transfer

Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

次要结局

  • Miscarriage rate(12 weeks gestational age)
  • Implantation rate(6 weeks after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Sayed Abdelhafez

Dr

Mansoura University

研究点 (2)

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