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

SEID S.A.

Status: Enrolling

Conditions: Reproductive Techniques, Assisted

Treatments: Dietary Supplement: Seidivid Ferty4; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05473039

OVOVID-FERTY4-2022-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

Seidivid Ferty4

Experimental group

Description:

Patients included in this group will be administered dietary supplement Seidivid Ferty4 (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH a).

Treatment:

Dietary Supplement: Seidivid Ferty4

Placebo

Placebo Comparator group

Description:

Patients included in this group will be administered placebo (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH-a).

Treatment:

Other: Placebo