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

IVF Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278508
• Other study ID #: 0155-19-HYMC
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: June 6, 2022

Study information

• Verified date: June 2022
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF

Intervention

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

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.	1 Year per patient
Secondary	Laboratory end other long term outcomes	chemical pregnancy rate, miscarriage rate, and live birth rates.	1 Year per patient