Progesterone Levels and Frozen Embryo Transfer Outcomes (PLATO)

November 19, 2025 updated by: Shady Grove Fertility Reproductive Science Center

Frozen embryo transfers (FET) now represent the majority of all embryo transfer cycles, and upwards of 60% live births in United States are now attributable to frozen embryo transfers (1). Exogenous progesterone for endometrial decidualization and luteal phase support is thought to be critical to both optimizing endometrial receptivity for implantation as well as sustaining early pregnancy prior to reliable secretory activity of the early placenta.

The purpose of this study is to:

  1. Determine the prevalence of low serum progesterone levels (less than 10 ng/ml) among patients undergoing a programmed embryo transfer cycle on the day of frozen embryo transfer.
  2. Determine if serum progesterone < 10 ng/ml on the day of frozen embryo transfer is associated with poorer FET outcomes: ongoing pregnancy (primary outcome), live birth, biochemical pregnancy, and clinical pregnancy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

659

Contacts and Locations

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

Study Contact

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing programmed frozen embryo transfer of a single euploid embryo with combined vaginal progesterone and intramuscular PIO.

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Female patient undergoing programmed frozen embryo transfer using exogenous estrogen and progesterone, with exogenous progesterone administered via a combination of vaginal progesterone (Endometrin®) (2-3 times daily) and intermittent progesterone-in-oil (PIO) (every 3rd day) according to standard protocol. Protocols involving other formulations of vaginal progesterone (e.g. Crinone®, Prometrium®, will also be included).
  3. Planned transfer one 1 euploid embryo. Recruited patients will have at least 1 euploid embryo available for transfer.
  4. Standard eligibility criteria to undergo frozen embryo transfer at Shady Grove Fertility.
  5. 18 years and older

Exclusion Criteria:

  1. Age less than 18 years or greater than 51 years
  2. Planned intervention based on serum progesterone concentration measured any time after initiation of intramuscular or vaginal progesterone.
  3. Uterine cavity abnormality that has not been surgically corrected.
  4. Any medical or surgical contraindication to undergoing programmed frozen embryo transfer or pregnancy.
  5. Planned use of embryos cryopreserved by slow-freeze, prior to blastocyst stage, or other than PGT-A normal.
  6. Currently breast feeding, pregnancy, or having a contraindication to pregnancy.
  7. Participation in any experimental drug study within 60 days prior to screening.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy
Time Frame: Through study completion, an average of 1 year
At the completion of the study, a chart review will be performed to determine which patients who participated in this study have an ongoing pregnancy. This information is recorded in our electronic medical record as a binary variable (ongoing pregnancy - yes or no).
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Shady Grove Fertility Reproductive Science Center

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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00089821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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