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

Study Overview
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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.

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

Conditions
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Infertility, Infertility, Female, IVF

Intervention / Treatment
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* Diagnostic Test: Measurement of serum progesterone on the day of FET


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of serum progesterone on the day of FET|Measurement of serum progesterone on the day of FET|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate per participant | Birth of a live fetus at 24 or more weeks of gestational age | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Biochemical pregnancy rate per participant | Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %) | 18 months | 
| Clinical pregnancy rate per participant | Presence of at least one gestational sac on ultrasound (number of events/number of participants, %) | 18 months | 
| Ectopic pregnancy rate per participant | number of events/number of participants, % | 18 months |