Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BLOOD COLLECTION FOR P4 DETERMINATION.
- Who it may be relevant to
- Registry conditions: Infertility, Female. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Procedure BLOOD COLLECTION FOR P4 DETERMINATION
Serum progesterone levels on the pregnancy test day
Primary outcome measures
- LIVE BIRTH [Time frame: 1 YEAR]
- ONGOING PREGNANCY [Time frame: 1 YEAR]
- POSITIVE PREGANCY [Time frame: 1 YEAR]
- BIOCHEMICAL MISCARRIAGE [Time frame: 1 YEAR]
- CLINICAL MISCARRIAGE [Time frame: 1 YEAR]
Secondary outcome measures (1)
- SERUM P4 LEVEL ON B-HCG DAY [Time frame: 1 YEAR]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- IVI RMA Valencia — Valencia
Publications
- 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. PMID 34177806
Identifiers
NCT: NCT05750849 · 2209-VLC-135-EL