Serum Progesterone Levels on the Day of Frozen Embryo Transfer (FET) and Pregnancy Outcomes (ProFET)

August 25, 2022 updated by: CARE Fertility UK
Frozen embryo transfer (FET) cycles have become more common in recent years due to a push towards elective single embryo transfer (SET). While it is known that progesterone supplementation during the luteal phase improves clinical pregnancy rates, there is a paucity of prospective data on the impact of serum progesterone levels on pregnancy outcomes in FET cycles. This multicentre prospective cohort study aims to investigate the association between serum progesterone levels on the day of FET and pregnancy outcomes, and to determine a serum progesterone cut-off value above which clinical pregnancy and live birth are more likely to occur. Women undergoing ART-FET cycles at CARE Fertility clinics in the UK will be recruited and their serum progesterone measured on the day of frozen embryo transfer. Follow-up data will be stored in electronic patient records and analysed to determine whether a low serum progesterone level on the day of FET adversely affects ART outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All women undergoing ART with FET.

Description

Inclusion Criteria:

  • All women undergoing ART with FET.

Exclusion Criteria:

  • None. We aim to study the "every day" patient undergoing FET, and for this we intend to keep the population of the study as unselected as possible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate per participant
Time Frame: 18 months
Birth of a live fetus at 24 or more weeks of gestational age
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate per participant and per pregnancy
Time Frame: 18 months
Any clinical pregnancy lost before week 12 of gestation per participant (number of events/number of participants, %)
18 months
Implantation rates per participant
Time Frame: 18 months
Number of gestational sacs seen in a 2D transvaginal ultrasound scan divided by the number of embryos transferred per patient (number of events/number of embryos transferred, %)
18 months
Biochemical pregnancy rate per participant
Time Frame: 18 months
Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %)
18 months
Clinical pregnancy rate per participant
Time Frame: 18 months
Presence of at least one gestational sac on ultrasound (number of events/number of participants, %)
18 months
Ectopic pregnancy rate per participant
Time Frame: 18 months
number of events/number of participants, %
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CARE Fertility UK

Investigators

  • Principal Investigator: Arri Coomarasamy, MBChB MD FRCOG, CARE Fertility UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProFETStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared with other researchers. Any IPD will be confined to the purposes of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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