Progesterone Levels and Frozen Embryo Transfer Outcomes | NCT07252622

Studies
Progesterone Levels and Frozen Embryo Transfer Outcomes

NCT07252622

Sponsor

Shady Grove Fertility Reproductive Science Center

Status

Not yet recruiting

Last Update Posted

Nov 28, 2025Actual

Enrollment

659Estimated

Phase

Not provided

Conditions

Interventions

Blood draw

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Nov 1, 2028Estimated

Completion Date

Nov 1, 2028Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 19, 2025

First Posted Date

Nov 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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.
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

659Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	All patients will have one additional blood draw on the day of their transfer to measure progesterone level.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
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).
Planned transfer one 1 euploid embryo. Recruited patients will have at least 1 euploid embryo available for transfer.
Standard eligibility criteria to undergo frozen embryo transfer at Shady Grove Fertility.
18 years and older

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis