An observational study in Infertility, Female, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational
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).
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.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's planned enrollment of 900 is above the median of 161 across 162 observational studies indexed under Infertility, Female.
Browse Infertility, Female studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All infertile patients undergoing an embryo transfer in the context of an artificial cycle will be recruited.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serum progesterone levels on β-hCG day over the threshold point calculated
Procedure: BLOOD COLLECTION FOR P4 DETERMINATION
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
LIVE BIRTH
Record of live birth existence
Time frame: 1 YEAR
ONGOING PREGNANCY
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
Time frame: 1 YEAR
POSITIVE PREGANCY
Measurement of pregnancy test results
Time frame: 1 YEAR
BIOCHEMICAL MISCARRIAGE
Measurement of existence of miscarriage after a positive pregnancy test
Time frame: 1 YEAR
CLINICAL MISCARRIAGE
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
Time frame: 1 YEAR
SERUM P4 LEVEL ON B-HCG DAY
Measurement of serum progesterone levels on the pregnancy test day
Time frame: 1 YEAR
Plan to share: Undecided
Started Jan 2023 (actual). Primary completion is estimated for Dec 2025, 35 months after the start.
Of 85 non-industry observational studies under Infertility, Female, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's planned 35 months is close to that.
Counting every sponsor, half of 88 studies reached it within 36 months; a quarter within 18 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Instituto Valenciano de Infertilidad, IVI VALENCIA