IVI RMA Valencia
Valencia, 46015, Spain
Location status: Recruiting
NCT Number: NCT05750849
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).
Interested in participating?
Request Info18 year–50 year
Female
Observational
Valencia, 46015, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Serum progesterone levels on the pregnancy test day
Time frame: 1 YEAR
Record of live birth existence
Time frame: 1 YEAR
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
Time frame: 1 YEAR
Measurement of pregnancy test results
Time frame: 1 YEAR
Measurement of existence of miscarriage after a positive pregnancy test
Time frame: 1 YEAR
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
Time frame: 1 YEAR
Measurement of serum progesterone levels on the pregnancy test day
Contact information is provided by the study sponsor or research team.
Instituto Valenciano de Infertilidad, IVI VALENCIA
Other
Acronym: P4-BETA
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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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