Reproductive Techniques, Assisted Clinical Trial
— OvoVidOfficial title:
OvoVid Study: Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality in Oocyte Donors. Double-blind Randomized Placebo-controlled Clinical Trial
Verified date | September 2023 |
Source | SEID S.A. |
Contact | Ana Gavilan |
Phone | +34938445730 |
agavilan[@]lab-seid.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of pretreatment with a multivitamin supplement with probiotics (Seidivid Ferty4®) on oocyte retrieval in normo-responder patients undergoing controlled ovarian hyperstimulation (COH) for oocyte donation, considering both the total number of oocytes retrieved and the number of mature oocytes retrieved, that is, in metaphase II (MII).
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 28, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility | Inclusion Criteria: - Women undergoing COH for egg donation cycles - Signing of Informed Consent - Age 18-34 years - Body mass index between 18-29.9 kg/m2 - Meet the criteria for inclusion in the oocyte donation program of the Next Fertility center - Ultrasound antral follicle count before COH of =15 follicles Exclusion Criteria: - Patients excluded from the oocyte donation program - Untreated sexually transmitted disease, HIV, HCV, HBV positive serology - Blood disorders, neurodegenerative/psychiatric diseases, fragile X syndrome, oncological diseases, endometriosis. - Polycystic ovary syndrome - Oligomenorrhea (<1 menstrual cycle in 3 months) - Diabetic patients |
Country | Name | City | State |
---|---|---|---|
Spain | NextFertility | Valencia |
Lead Sponsor | Collaborator |
---|---|
SEID S.A. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocytes retrieved | Total number of oocytes retrieved in the follicular puncture | Through study completion, an average of 42 days | |
Primary | Number of mature (MII) oocytes retrieved | Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture | Through study completion, an average of 42 days | |
Secondary | Rate of normal or good quality oocytes | Percentage of mature oocytes MII without dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | |
Secondary | Rate of oocytes with dimorphisms | Percentage of mature oocytes MII with dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | |
Secondary | Rate of oocytes with intra-cytoplasmic dimorphisms | Percentage of mature oocytes MII with intra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | |
Secondary | Rate of oocytes with extra-cytoplasmic dimorphisms | Percentage of mature oocytes MII with extra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | |
Secondary | Number of antral follicles at study inclusion | Ultrasound antral follicle count at study inclusion | Baseline | |
Secondary | Number of antral follicles at the time of COH start | Ultrasound antral follicle count at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | |
Secondary | Number of follicles at the time of trigger administration | Ultrasound follicle count at the time of trigger administration | Through trigger administration, an average of 40 days | |
Secondary | Baseline fasting glucose | Fasting blood glucose at the time of study inclusion | Baseline | |
Secondary | Fasting glucose at the time of COH start | Fasting blood glucose at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | |
Secondary | Baseline AST | Serum aspartate aminotransferase (AST) levels at the time of study inclusion | Baseline | |
Secondary | AST at the time of COH start | Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | |
Secondary | Baseline ALT | Serum alanine aminotransferase (ALT) levels at the time of study inclusion | Baseline | |
Secondary | ALT at the time of COH start | Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | |
Secondary | Baseline Cholesterol | Total cholesterol at the time of study inclusion | Baseline | |
Secondary | Cholesterol at the time of COH start | Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | |
Secondary | LH at the time of COH start | Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days |
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