Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
P4-BETA
1 other identifier
observational
900
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2023
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 20, 2025
July 1, 2025
2.9 years
February 20, 2023
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
SERUM P4 LEVEL ON B-HCG DAY
1 YEAR
Study Arms (2)
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
Interventions
Serum progesterone levels on the pregnancy test day
Eligibility Criteria
All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.
You may qualify if:
- 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
You may not qualify if:
- Uterine Pathology, adnexal pathology
- Systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI RMA Valencia
Valencia, Valencia, 46015, Spain
Related Publications (1)
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: 34177806BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 2, 2023
Study Start
January 25, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
July 20, 2025
Record last verified: 2025-07