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

NCT ID: NCT04278508

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2022-06-06

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.

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.

Conditions

IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

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

Group B

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

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

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

Group C

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

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

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

Interventions

Progesterone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Einat Shalom-Paz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

Hillel Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Other Identifiers

0155-19-HYMC

Identifier Type: -

Identifier Source: org_study_id