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NCT Number: NCT05750849

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

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).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLOOD COLLECTION FOR P4 DETERMINATION

Procedure

Serum progesterone levels on the pregnancy test day

Primary outcomes

  1. LIVE BIRTH

    Time frame: 1 YEAR

    Record of live birth existence

  2. ONGOING PREGNANCY

    Time frame: 1 YEAR

    Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound

  3. POSITIVE PREGANCY

    Time frame: 1 YEAR

    Measurement of pregnancy test results

  4. BIOCHEMICAL MISCARRIAGE

    Time frame: 1 YEAR

    Measurement of existence of miscarriage after a positive pregnancy test

  5. CLINICAL MISCARRIAGE

    Time frame: 1 YEAR

    Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound

Secondary outcomes

  1. SERUM P4 LEVEL ON B-HCG DAY

    Time frame: 1 YEAR

    Measurement of serum progesterone levels on the pregnancy test day

Study contacts

Contact information is provided by the study sponsor or research team.

LAURA CARACENA, MSR

CONTACT

[email protected]

034 963 050 900

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Acronym: P4-BETA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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