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OpenTrials
Completed

NCT Number: NCT04170517

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

CARE Fertility Birmingham

Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurement of serum progesterone on the day of FET

Diagnostic Test

Measurement of serum progesterone on the day of FET

Primary outcomes

  1. Live birth rate per participant

    Time frame: 18 months

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

Secondary outcomes

  1. Miscarriage rate per participant and per pregnancy

    Time frame: 18 months

    Any clinical pregnancy lost before week 12 of gestation per participant (number of events/number of participants, %)

  2. Implantation rates per participant

    Time frame: 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, %)

  3. Biochemical pregnancy rate per participant

    Time frame: 18 months

    Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %)

  4. Clinical pregnancy rate per participant

    Time frame: 18 months

    Presence of at least one gestational sac on ultrasound (number of events/number of participants, %)

  5. Ectopic pregnancy rate per participant

    Time frame: 18 months

    number of events/number of participants, %

Sponsors and collaborators

Lead sponsor

CARE Fertility UK

Other

Registry information

Acronym: ProFET

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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