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临床试验/NCT02825290
NCT02825290Unknown4 期

Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
62
试验地点
1
主要终点
Ongoing pregnancy

研究概览

简要总结

This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.

详细描述

Background With the recent trend toward single embryo transfer (ET) adopted in an attempt to reduce the risk of multiple pregnancy, the remaining extra embryos are cryopreserved, providing further possibilities for conception after the initial fresh transfer. Moreover, several studies that compared fresh and frozen-thawed embryo transfer (FET) cycles in normal responders have demonstrated a significantly higher clinical pregnancy rate per transfer in the FET versus the fresh cycles.

There are several currently employed replacement protocols for FET. The choice of protocol depends on the individual woman's ovarian function and convenience of the method, as well as on the experience gained with the method by the physicians. Whatever protocol is used, the success requires optimal synchronization between the embryonic stage at thawing and date of the endometrium within the endometrial preparation cycle. While there is a consensus regarding the duration, route of delivery and dosage of estrogen supplementation, and the optimal ultrasonographic endometrial appearance and thickness, the effect of the different modes of luteal support remains unclear.

Prompted by the study demonstrating higher ongoing pregnancy rate following the transfer of frozen-thawed embryos in natural cycles with spontaneous LH rise compared with natural cycles controlled by hCG for final oocyte maturation and the reports showing improved pregnancy rate in patients who received a mid-luteal injection of a GnRH-agonist (0.1 mg triptorelin), the investigators started beginning at June 2014 to offer ovulatory patients with regular menstrual cycles a natural FET with modified luteal support. Starting on the day of spontaneous ovulation, patients received daily vaginal progesterone, supplemented by a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively.

The results for this study were very promising - the investigators were able to show a significant increase in implantation rate (30% vs. 17%; p<0.03), clinical pregnancy (48% vs. 26%; p<0.01) and ongoing pregnancy (39% vs. 20%; p<0.01) for the patients receiving the aforementioned modified luteal support protocol.

After the completion of this retrospective study the investigators are heading to prove the superiority of the modified luteal support protocol for ovulatory patients by conducting a prospective study.

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 (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 20-40 years old women
  • Spontaneously ovulating women
  • Treated in our IVF unit for frozen-thawed embryo transfer
  • At least one top quality embryo

排除标准

  • PGD patients
  • More than 4 previous embryo transfers

研究组 & 干预措施

Study group

Experimental

hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer & GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support.

干预措施: Choriogonadotropin alfa (Drug)

Study group

Experimental

hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer & GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support.

干预措施: Triptorelin acetate (Drug)

结局指标

主要结局

Ongoing pregnancy

时间窗: About 10-12 weeks after embryo transfer

Number of viable pregnancies at about 10-12 weeks of gestation.

次要结局

  • Implantation rate(2 weeks after embryo transfer)
  • Clinical pregnancy(About 3-4 weeks after embryo transfer)

研究者

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

Dr. Eran Zilberberg

Doctor

Sheba Medical Center

研究点 (1)

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