Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.

Study Overview
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Brief Summary
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Prospective cohort multicentric study including infertile patients undergoing a pregnancy test on βhCG day (around ET +11), after an ET in the context of an artificial cycle and receiving LPS with vaginal natural progesterone following the clinical practice in IVI RMA (Spain).

Detailed Description
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The investigation team have already demonstrated that serum progesterone levels measured on the ET day in artificial cycles are related to pregnancy outcome. In this line, this problem can be countteracted after supplementation with an additional source of external progesterone, achieving similar ongoing pregnancy and live birth rates in women with serum progesterone levels below and above the threshold point determined on the ET day. Despite this, it has been observed apparent differences on the maintenance of pregnancy in patients with a positive pregnancy test according to their serum progesterone levels measured on day ET+11, which is the same day in which we perform the pregnancy test. These differences seem to be originated due to later higher clinical miscarriage rates in patients with lower serum progesterone levels on day ET+11, despite their positive pregnancy test. This fact may be due to patientes low serum progesterone levels, insufficient to maintain an ongoing pregnancy. Taking this into account, this study aim to confirm that serum progesterone levels on βhCG day are indeed related to final pregnancy outcome and to evaluate if there is any cut-off point of serum progesterone levels, as we have previously found on the ET day.

Official Title
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Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.

Conditions
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Infertility, Female

Intervention / Treatment
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* Procedure: BLOOD COLLECTION FOR P4 DETERMINATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must provide written informed consent prior to any study related procedures Women ≤50 years old BMI ≤ 35 kg/m2 Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase Exclusion Criteria: Uterine Pathology, adnexal pathology Systemic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OPTIMAL SERUM P4 LEVEL<br>Serum progesterone levels on β-hCG day over the threshold point calculated | Procedure: BLOOD COLLECTION FOR P4 DETERMINATION<br>* Serum progesterone levels on the pregnancy test day<br>|
| SUB-OPTIMAL SERUM P4 LEVEL<br>Serum progesterone levels on β-hCG day below the threshold point calculated | Procedure: BLOOD COLLECTION FOR P4 DETERMINATION<br>* Serum progesterone levels on the pregnancy test day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LIVE BIRTH | Record of live birth existence | 1 YEAR | 
| ONGOING PREGNANCY | Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound | 1 YEAR | 
| POSITIVE PREGANCY | Measurement of pregnancy test results | 1 YEAR | 
| BIOCHEMICAL MISCARRIAGE | Measurement of existence of miscarriage after a positive pregnancy test | 1 YEAR | 
| CLINICAL MISCARRIAGE | Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SERUM P4 LEVEL ON B-HCG DAY | Measurement of serum progesterone levels on the pregnancy test day | 1 YEAR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SERUM PROGESTERONE, LATE LUETEAL PHASE, ONGOING PREGNANCY RATE, ARTIFICIAL CYCLE, LUTEAL PHASE SUPPORT, EMBRYO TRANSFER