P4-BETA: Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OPTIMAL SERUM P4 LEVEL Serum progesterone levels on β-hCG day over the threshold point calculated |
Procedure: BLOOD COLLECTION FOR P4 DETERMINATION
Serum progesterone levels on the pregnancy test day
|
| SUB-OPTIMAL SERUM P4 LEVEL Serum progesterone levels on β-hCG day below the threshold point calculated |
Procedure: BLOOD COLLECTION FOR P4 DETERMINATION
Serum progesterone levels on the pregnancy test day
|
Outcome Measures
Primary Outcome Measures
- LIVE BIRTH [1 YEAR]
Record of live birth existence
- ONGOING PREGNANCY [1 YEAR]
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
- POSITIVE PREGANCY [1 YEAR]
Measurement of pregnancy test results
- BIOCHEMICAL MISCARRIAGE [1 YEAR]
Measurement of existence of miscarriage after a positive pregnancy test
- CLINICAL MISCARRIAGE [1 YEAR]
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
Secondary Outcome Measures
- SERUM P4 LEVEL ON B-HCG DAY [1 YEAR]
Measurement of serum progesterone levels on the pregnancy test day
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject must provide written informed consent prior to any study related procedures
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Women ≤50 years old
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BMI ≤ 35 kg/m2
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Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase
Exclusion Criteria:
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Uterine Pathology, adnexal pathology
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Systemic diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IVI RMA Valencia | Valencia | Spain | 46015 |
Sponsors and Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2209-VLC-135-EL