Infertility, FemaleP4-BETANCT05750849
Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
An observational study of Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- BLOOD COLLECTION FOR P4 DETERMINATION
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.
Who may be able to join
- 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
Who cannot join
- Uterine Pathology, adnexal pathology
- Systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IVI RMA Valencia
Valencia, Valencia, 46015
Elena Labarta, MD, PhD, +34963050900, elena.labarta@ivirma.com
About this study
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).
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- BLOOD COLLECTION FOR P4 DETERMINATION
- Keywords
- SERUM PROGESTERONE, LATE LUETEAL PHASE, ONGOING PREGNANCY RATE, ARTIFICIAL CYCLE, LUTEAL PHASE SUPPORT, EMBRYO TRANSFER
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD COLLECTION FOR P4 DETERMINATIONProcedure or surgery
Serum progesterone levels on the pregnancy test day
| Study group | Role | What they receive |
|---|---|---|
| OPTIMAL SERUM P4 LEVEL | Serum progesterone levels on β-hCG day over the threshold point calculated Receives: Procedure: BLOOD COLLECTION FOR P4 DETERMINATION | |
| SUB-OPTIMAL SERUM P4 LEVEL | Serum progesterone levels on β-hCG day below the threshold point calculated Receives: Procedure: BLOOD COLLECTION FOR P4 DETERMINATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIVE BIRTH
Record of live birth existence
Measured: 1 YEAR
ONGOING PREGNANCY
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
Measured: 1 YEAR
POSITIVE PREGANCY
Measurement of pregnancy test results
Measured: 1 YEAR
BIOCHEMICAL MISCARRIAGE
Measurement of existence of miscarriage after a positive pregnancy test
Measured: 1 YEAR
CLINICAL MISCARRIAGE
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
Measured: 1 YEAR
Secondary outcomes (1)
SERUM P4 LEVEL ON B-HCG DAY
Measurement of serum progesterone levels on the pregnancy test day
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start25 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750849
- Sponsor's protocol ID
- 2209-VLC-135-EL
- Acronym
- P4-BETA
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34177806
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
- ClinicalTrials.gov ID
- NCT05750849
- Acronym / sponsor ID
- P4-BETA / 2209-VLC-135-EL
- Conditions
- Infertility, Female
- Keywords
- SERUM PROGESTERONE, LATE LUETEAL PHASE, ONGOING PREGNANCY RATE, ARTIFICIAL CYCLE, LUTEAL PHASE SUPPORT, EMBRYO TRANSFER
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTIMAL SERUM P4 LEVEL | – | Procedure: BLOOD COLLECTION FOR P4 DETERMINATIONSerum progesterone levels on β-hCG day over the threshold point calculated |
| SUB-OPTIMAL SERUM P4 LEVEL | – | Procedure: BLOOD COLLECTION FOR P4 DETERMINATIONSerum progesterone levels on β-hCG day below the threshold point calculated |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Uterine Pathology, adnexal pathology
- Systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLOOD COLLECTION FOR P4 DETERMINATIONSerum progesterone levels on the pregnancy test day | Procedure or surgery | OPTIMAL SERUM P4 LEVEL, SUB-OPTIMAL SERUM P4 LEVEL |
Primary outcome
LIVE BIRTH
Time frame: 1 YEAR
Record of live birth existence
ONGOING PREGNANCY
Time frame: 1 YEAR
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
POSITIVE PREGANCY
Time frame: 1 YEAR
Measurement of pregnancy test results
BIOCHEMICAL MISCARRIAGE
Time frame: 1 YEAR
Measurement of existence of miscarriage after a positive pregnancy test
CLINICAL MISCARRIAGE
Time frame: 1 YEAR
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
1 secondary outcome
SERUM P4 LEVEL ON B-HCG DAY
Time frame: 1 YEAR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Results publication: PubMed 34177806Labarta 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURA CARACENA, MSR (034 963 050 900, LAURA.CARACENA@IVIRMA.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIVE BIRTH (time frame: 1 YEAR). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.