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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 196
- Locations
- 2
- Primary Endpoint
- Number of Oocytes Retrieved
Study Overview
Brief Summary
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).
Detailed Description
Patients will be recruited on the day they are going to start the egg donation program. The patient will start taking the study treatment (multivitamin supplement with probiotics or placebo) immediately after inclusion and will call the site to initiate the oocyte donation protocol approximately 30 days after enrollment. Throughout the COH period of the protocol the patient will continue taking the study supplement (or placebo), without interruption until the day of the GnRH-agonist trigger. The administration of the agonist will be as a single dose, 36 hours before follicular puncture for the retrieval of mature eggs. Then, the retrieved oocytes will be denuded and examined by light microscopy to assess their quality. The evaluation will carried out by two different embryologists, blinded to the study protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study multivitamin product with probiotics (Seidivid Ferty4®) and placebo will be supplied as capsules with an identical external appearance packaged in blisters in a white box with no label, marked only with the study code and patient code.
Eligibility Criteria
- Ages
- 18 Years to 34 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Oocytes Retrieved
Time Frame: Through study completion, an average of 42 days
Total number of oocytes retrieved in the follicular puncture
Number of Mature (MII) Oocytes Retrieved
Time Frame: Through study completion, an average of 42 days
Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture
Secondary Outcomes
- Number of Good Quality Oocytes(Through study completion, an average of 42 days)
- Number of Oocytes With Dimorphisms(Through study completion, an average of 42 days)
- Number of Follicles at the Time of Trigger Administration(Through trigger administration, an average of 40 days)
- Fasting Glucose After 30 Days of Treatment With Dietary Supplement.(Through COH start, an average of 30 days)
- AST After 30 Days of Treatment With Dietary Supplement.(Through COH start, an average of 30 days)
- ALT After 30 Days of Treatment With Dietary Supplement.(Through COH start, an average of 30 days)
- Cholesterol After 30 Days of Treatment With Dietary Supplement.(Through COH start, an average of 30 days)
- LH at the Time of COH Start(Through COH start, an average of 30 days)