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临床试验/CTRI/2025/03/082224
CTRI/2025/03/082224尚未招募不适用

Association of serum estradiol and progesterone levels one day prior to frozen embryo transfer with clinical pregnancy outcome

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Intrauterine gestational sac with cardiac activity

研究概览

简要总结

Frozen embryo transfer (FET) has increased in prevalence amongall ART cycles. As use increases it is important to identify factors that improve outcomes. Several known predictors include age,number, and quality of frozen embryos. Another vital aspect is the ‘window of implantation’1, the period when the endometrium is most receptive.2 Progesterone is essential for support of the endometrium and implantation of an embryo in the normal menstrual cycle. This state is induced through an interplay of hormones including estrogen and progesterone.3 When performing FETs an attempt is made to replicate the natural hormonal environment.

GnRH agonist is administered for pituitary down regulation which in turn inhibits the secretion of LH and disturbs endogenous production of progesterone. As the endogenous production of progesterone requires a functioning corpus luteum that is not present in programed cycles., Therefore progesterone supplementation is recommended in these women as luteal phase support to make endometrium secretory and maintain pregnancy4.Hormone replacement therapy (HRT) comprising of both estradiol and progesterone was given to the patients.

According to previously established studies, progesterone luteal support increases the clinical outcome of FETs. Patients who received progesterone luteal support had higher clinical and biochemical pregnancies with increased chances of live birth and lower miscarriage rate.

Even though the adequate level of progesterone on the day of embryo transfer has an undeniable effect on clinical outcomes of FET, there are growing pieces of evidence regarding the nonlinearassociation between serum progesterone levels and such outcomes. There is an optimal window for progesterone values in luteal phases that is in controversy with the traditional belief that higher values of progesterone will lead to better clinical outcomes in FET. If the progesterone level is above an optimum level, this may decrease the pregnancy rate. It might be due to premature luteinization and its subsequent impairment in receptivity of the endometrium.5-8 This study is undertaken to determine the association of serum estradiol and progesterone levels one day prior to FET with the clinical pregnancy rate.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • All patients needing frozen embryo transfer will undergo endometrial preparation with estradiol valerate followed by micronised progesterone 100 mg I/m.
  • Once endometrial thickness becomes more than equal to 7mm and both ovaries show non dominant follicles on TVS .
  • FET in done.

排除标准

  • 未提供

结局指标

主要结局

Intrauterine gestational sac with cardiac activity

时间窗: 4 weeks

次要结局

  • Pregnancy of unknown origin(Ectopic pregnancy)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college

研究点 (1)

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