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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTIMAL SERUM P4 LEVEL | Serum progesterone levels on β-hCG day over the threshold point calculated |
| |
| SUB-OPTIMAL SERUM P4 LEVEL | Serum progesterone levels on β-hCG day below the threshold point calculated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLOOD COLLECTION FOR P4 DETERMINATION | Procedure | Serum progesterone levels on the pregnancy test day |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SERUM P4 LEVEL ON B-HCG DAY | Measurement of serum progesterone levels on the pregnancy test day | 1 YEAR |
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Inclusion Criteria:
Exclusion Criteria:
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All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LAURA CARACENA, MSR | Contact | 034 963 050 900 | LAURA.CARACENA@IVIRMA.COM |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI RMA Valencia | Recruiting | Valencia | Valencia | 46015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34177806 | Result | Labarta E, Rodriguez-Varela C, Mariani G, Bosch E. Serum Progesterone Profile Across the Mid and Late Luteal Phase in Artificial Cycles Is Associated With Pregnancy Outcome. Front Endocrinol (Lausanne). 2021 Jun 10;12:665717. doi: 10.3389/fendo.2021.665717. eCollection 2021. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |