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

NCT04170517 | Completed

• 1 other identifier: ProFETStudy
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; Infertility, Female; IVF

Outcome Measures

Primary Outcomes (1)

• Live birth rate per participant

  Birth of a live fetus at 24 or more weeks of gestational age

  18 months

Secondary Outcomes (5)

• Miscarriage rate per participant and per pregnancy

  18 months

• Implantation rates per participant

  18 months

• Biochemical pregnancy rate per participant

  18 months

• Clinical pregnancy rate per participant

  18 months

• Ectopic pregnancy rate per participant

  18 months

Interventions

Measurement of serum progesterone on the day of FET DIAGNOSTIC_TEST

Measurement of serum progesterone on the day of FET

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women undergoing ART with FET.

You may qualify if:

• All women undergoing ART with FET.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CARE Fertility UK: lead

Study Sites (1)

CARE Fertility Birmingham

Birmingham, United Kingdom

Location

Related Publications (1)

• Melo P, Wood S, Petsas G, Chung Y, Easter C, Price MJ, Fishel S, Khairy M, Kingsland C, Lowe P, Rajkhowa M, Sephton V, Pandey S, Kazem R, Walker D, Gorodeckaja J, Wilcox M, Gallos I, Tozer A, Coomarasamy A. The effect of frozen embryo transfer regimen on the association between serum progesterone and live birth: a multicentre prospective cohort study (ProFET). Hum Reprod Open. 2022 Nov 28;2022(4):hoac054. doi: 10.1093/hropen/hoac054. eCollection 2022.

  PMID: 36518987 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum progesterone will be measured from consenting participants on the day of frozen embryo transfer.

MeSH Terms

Conditions

Infertility; Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Arri Coomarasamy, MBChB MD FRCOG

  CARE Fertility UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 20, 2019
• Study Start: January 2, 2020
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)