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

NCT ID: NCT04170517

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-02

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Infertility, Female IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Measurement of serum progesterone on the day of FET

Measurement of serum progesterone on the day of FET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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CARE Fertility UK

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arri Coomarasamy, MBChB MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

CARE Fertility UK

Locations

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CARE Fertility Birmingham

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36518987 (View on PubMed)

Other Identifiers

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ProFETStudy

Identifier Type: -

Identifier Source: org_study_id

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