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Completed

NCT Number: NCT04278508

Serum Progesterone on the Day of Thawed Embryo Transfer and Pregnancy Rate After an Artificial Endometrial Preparation

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.

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Key information

Conditions

IVF

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hillel Yaffe Medical Center

Hadera, 381000, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Progesterone

Drug

To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 1 Year per patient

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

Secondary outcomes

  1. Laboratory end other long term outcomes

    Time frame: 1 Year per patient

    chemical pregnancy rate, miscarriage rate, and live birth rates.

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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