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

Infertility Clinical Trial

— ProFET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170517
• Other study ID #: ProFETStudy
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: CARE Fertility UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• IVF

Intervention

Diagnostic Test:
• Measurement of serum progesterone on the day of FET
Measurement of serum progesterone on the day of FET

Locations

Country	Name	City	State
United Kingdom	CARE Fertility Birmingham	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
CARE Fertility UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate per participant	Birth of a live fetus at 24 or more weeks of gestational age	18 months
Secondary	Miscarriage rate per participant and per pregnancy	Any clinical pregnancy lost before week 12 of gestation per participant (number of events/number of participants, %)	18 months
Secondary	Implantation rates per participant	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, %)	18 months
Secondary	Biochemical pregnancy rate per participant	Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %)	18 months
Secondary	Clinical pregnancy rate per participant	Presence of at least one gestational sac on ultrasound (number of events/number of participants, %)	18 months
Secondary	Ectopic pregnancy rate per participant	number of events/number of participants, %	18 months