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

Recruiting

• Conditions: Infertility, Female
• Interventions: Procedure: BLOOD COLLECTION FOR P4 DETERMINATION

• Registration Number: NCT05750849
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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).

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 Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUB-OPTIMAL SERUM P4 LEVEL	BLOOD COLLECTION FOR P4 DETERMINATION	Serum progesterone levels on β-hCG day below the threshold point calculated
OPTIMAL SERUM P4 LEVEL	BLOOD COLLECTION FOR P4 DETERMINATION	Serum progesterone levels on β-hCG day over the threshold point calculated

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SERUM P4 LEVEL ON B-HCG DAY	1 YEAR	Measurement of serum progesterone levels on the pregnancy test day

Trial Locations

Locations (1)

IVI RMA Valencia; 🇪🇸 Valencia, Spain