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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04278508
Collaborator
(none)
38
1
3
26.9
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Mar 9, 2020
Actual Primary Completion Date :
Jun 6, 2022
Actual Study Completion Date :
Jun 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

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

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

Active Comparator: Group B

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

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

Active Comparator: Group C

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

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

Outcome Measures

Primary Outcome Measures

  1. Clinical pregnancy rate [1 Year per patient]

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

Secondary Outcome Measures

  1. Laboratory end other long term outcomes [1 Year per patient]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hillel Yaffe Medical Center Hadera Israel 381000

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Einat Shalom-Paz, Prof., Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT04278508
Other Study ID Numbers:
  • 0155-19-HYMC
First Posted:
Feb 20, 2020
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2022