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

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).

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: BLOOD COLLECTION FOR P4 DETERMINATION

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 Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: LAURA CARACENA, MSR; Phone Number: 034 963 050 900; Email: LAURA.CARACENA@IVIRMA.COM

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Recruiting
    • IVI RMA Valencia
    • Contact: Elena Labarta, MD, PhD; Phone Number: +34963050900; Email: elena.labarta@ivirma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OPTIMAL SERUM P4 LEVEL; Serum progesterone levels on β-hCG day over the threshold point calculated	Procedure: BLOOD COLLECTION FOR P4 DETERMINATION; Serum progesterone levels on the pregnancy test day
SUB-OPTIMAL SERUM P4 LEVEL; Serum progesterone levels on β-hCG day below the threshold point calculated	Procedure: BLOOD COLLECTION FOR P4 DETERMINATION; Serum progesterone levels on the pregnancy test day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SERUM P4 LEVEL ON B-HCG DAY	Measurement of serum progesterone levels on the pregnancy test day	1 YEAR

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ONGOING PREGNANCY RATE; EMBRYO TRANSFER; SERUM PROGESTERONE; LATE LUETEAL PHASE; ARTIFICIAL CYCLE; LUTEAL PHASE SUPPORT
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 2209-VLC-135-EL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No