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临床试验/NCT04278508
NCT04278508已完成不适用

Is There an Association Between Low Serum Progesterone on the Day of Frozen-thawed Embryo Transfer and a Reduced Clinical Pregnancy Rate After an Artificial Endometrial Preparation: A Randomized Control Trial

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年3月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR.

详细描述

Over the past decade, the use of frozen-thawed embryo transfer (FET) has risen around the globe. There is no consensus which mode of FET is superior, either natural cycle (NC) or artificial cycle (AC) with hormonal replacement therapy (HRT). The latter has become more and more popular because it allows more flexibility in timing of FET and it requires fewer visits for monitoring before the transfer. AC also has the advantage of a more precise control of progesterone (P) exposure, which is of utmost importance for controlling the window of implantation between the embryo and the endometrium. Although FET in AC give excellent results, there is still a need for improvement, as the ideal dose is not individualized to a patient's characteristics and serum P required for optimal cycle outcome haven't been established.

Retrospective studies about P levels on the day of FET in AC cycles showed contradictory results regarding cycle outcomes. Several studies showed that a lower P levels on FET day, or one day prior, are associated with lower clinical pregnancy rate (CPR) or live birth rate (LBR), whereas one study showed that women with higher P on FET day were having lower LBRs. Recently, a prospective study showed that serum P level < 9.2 ng/ml on the day of FET in oocyte reception cycles was associated with a significant lower ongoing pregnancy rate. Considering these previous studies, we wanted to determine if different serum P levels on FET day are associated with different CPR, and if increasing dosage of vaginal P in cases of lower serum P level on FET day can be either beneficial or detrimental.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women between age 18-38 undergoing FET in AC
  • with body mass index (BMI) < 35 kg/m2
  • a triple layer endometrium >6.5 mm after exogenous estrogen administration
  • 1-2 good quality day 3 or 5 FET.

排除标准

  • women with recurrent pregnancy losses (e.g. 2 abortions beyond 12th week or 3 abortions before 12th week)
  • recurrent implantation failure (e.g. unsuccessful implantation of ≥4 good quality embryos)
  • severe male factor (sperm concentration <5 million/ml), or presence of hydrosalpinx.

研究组 & 干预措施

Group B

Active Comparator

P < 10.0 ng/ml without change in drug regimen.

干预措施: Progesterone (Drug)

Group C

Active Comparator

P ≥ 10.0 ng/ml without change in drug regimen.

干预措施: Progesterone (Drug)

Group A

Active Comparator

P < 10.0 ng/ml with increasing P dosage from 800 mg to 1200 mg daily from the FET day.

干预措施: Progesterone (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 1 Year per patient

Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.

次要结局

  • Laboratory end other long term outcomes(1 Year per patient)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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