Progesterone Levels and Frozen Embryo Transfer Outcomes

NCT ID: NCT07252622

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 659 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-11-01

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:

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.

Conditions

IVF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blood draw

All patients will have one additional blood draw on the day of their transfer to measure progesterone level.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shady Grove Fertility Reproductive Science Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David Boedeker

Role: CONTACT

platostudy@sgfertility.com

301-545-1423

Other Identifiers

Pro00089821

Identifier Type: -

Identifier Source: org_study_id