Evaluation of Salivary ELISA for Hormone Monitoring in Donors
NCT ID: NCT05780489
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-04-14
2024-12-31
Brief Summary
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Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.
The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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DONORS UNDER CONTROLLED OVARIAN STIMULATION
Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.
Determination of progesterone and oestradiol
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
Interventions
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Determination of progesterone and oestradiol
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
Eligibility Criteria
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Inclusion Criteria
* Woman undergoing COS for oocyte donation
* Age 18-35, inclusive
* Regular menstrual cycles
* In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study
Exclusion Criteria
18 Years
35 Years
FEMALE
No
Sponsors
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MINT DIAGNOSTICS
UNKNOWN
Instituto Valenciano de Infertilidad, IVI VALENCIA
OTHER
Responsible Party
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Locations
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Ivi Madrid
Madrid, , Spain
IVI Valencia
Valencia, , Spain
Countries
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Facility Contacts
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Other Identifiers
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2211-VLC-158-EB
Identifier Type: -
Identifier Source: org_study_id
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