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

Completed

• Conditions: IVF; Infertility; Infertility, Female

• Registration Number: NCT04170517
• Lead Sponsor: CARE Fertility UK

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2020-01-02
• Primary Completion: 2021-02-28
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth rate per participant	18 months	Birth of a live fetus at 24 or more weeks of gestational age

Secondary Outcome Measures

Name	Time	Method
Implantation rates per participant	18 months	Number of gestational sacs seen in a 2D transvaginal ultrasound scan divided by the number of embryos transferred per patient (number of events/number of embryos transferred, %)
Biochemical pregnancy rate per participant	18 months	Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %)
Miscarriage rate per participant and per pregnancy	18 months	Any clinical pregnancy lost before week 12 of gestation per participant (number of events/number of participants, %)
Ectopic pregnancy rate per participant	18 months	number of events/number of participants, %
Clinical pregnancy rate per participant	18 months	Presence of at least one gestational sac on ultrasound (number of events/number of participants, %)

Trial Locations

Locations (1)

CARE Fertility Birmingham; 🇬🇧 Birmingham, United Kingdom