- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278508
Serum Progesterone on the Day of Thawed Embryo Transfer and Pregnancy Rate After an Artificial Endometrial Preparation
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hadera, Israel, 381000
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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.
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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.
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To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical pregnancy rate
Time Frame: 1 Year per patient
|
Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.
|
1 Year per patient
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratory end other long term outcomes
Time Frame: 1 Year per patient
|
chemical pregnancy rate, miscarriage rate, and live birth rates.
|
1 Year per patient
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Einat Shalom-Paz, Prof., Hillel Yaffe Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0155-19-HYMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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