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

Infertility, Female Clinical Trial

— P4-BETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750849
• Other study ID #: 2209-VLC-135-EL
• Status: Recruiting
• Start date: January 25, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: LAURA CARACENA, MSR
• Phone: 034 963 050 900
• Email: LAURA.CARACENA[@]IVIRMA.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• BLOOD COLLECTION FOR P4 DETERMINATION
Serum progesterone levels on the pregnancy test day

Locations

Country	Name	City	State
Spain	IVI RMA Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

References & 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.2021.66571 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LIVE BIRTH	Record of live birth existence	1 YEAR
Primary	ONGOING PREGNANCY	Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound	1 YEAR
Primary	POSITIVE PREGANCY	Measurement of pregnancy test results	1 YEAR
Primary	BIOCHEMICAL MISCARRIAGE	Measurement of existence of miscarriage after a positive pregnancy test	1 YEAR
Primary	CLINICAL MISCARRIAGE	Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound	1 YEAR
Secondary	SERUM P4 LEVEL ON B-HCG DAY	Measurement of serum progesterone levels on the pregnancy test day	1 YEAR