Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate. (P4-BETA)

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status: Enrolling

Conditions: Infertility, Female

Treatments: Procedure: BLOOD COLLECTION FOR P4 DETERMINATION

Study type: Observational

Funder types: Other

Identifiers

NCT05750849

2209-VLC-135-EL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

900 participants in 2 patient groups

OPTIMAL SERUM P4 LEVEL

Description:

Serum progesterone levels on β-hCG day over the threshold point calculated

Treatment:

Procedure: BLOOD COLLECTION FOR P4 DETERMINATION

SUB-OPTIMAL SERUM P4 LEVEL

Description:

Serum progesterone levels on β-hCG day below the threshold point calculated

Treatment:

Procedure: BLOOD COLLECTION FOR P4 DETERMINATION