Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality

Not Applicable

Completed

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.

Recruitment & 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

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	Through study completion, an average of 42 days	Total number of oocytes retrieved in the follicular puncture
Number of Mature (MII) Oocytes Retrieved	Through study completion, an average of 42 days	Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture

Secondary Outcome Measures

Name	Time	Method
Number of Good Quality Oocytes	Through study completion, an average of 42 days	Number of oocytes MII without dimorphisms
Number of Oocytes With Dimorphisms	Through study completion, an average of 42 days	Number of mature oocytes MII with dimorphisms
Number of Follicles at the Time of Trigger Administration	Through trigger administration, an average of 40 days	Ultrasound follicle count at the time of trigger administration
Fasting Glucose After 30 Days of Treatment With Dietary Supplement.	Through COH start, an average of 30 days	Fasting blood glucose at the start of controlled ovarian hyperstimulation (COH)
AST After 30 Days of Treatment With Dietary Supplement.	Through COH start, an average of 30 days	Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start
ALT After 30 Days of Treatment With Dietary Supplement.	Through COH start, an average of 30 days	Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start
Cholesterol After 30 Days of Treatment With Dietary Supplement.	Through COH start, an average of 30 days	Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start
LH at the Time of COH Start	Through COH start, an average of 30 days	Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start