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

NCT05473039 | Completed Results

• 1 other identifier: OVOVID-FERTY4-2022-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Reproductive Techniques, Assisted

Keywords

oocyte maduration; oocyte donation; dietary supplement

Outcome Measures

Primary Outcomes (2)

• Number of Oocytes Retrieved

  Total number of oocytes retrieved in the follicular puncture

  Through study completion, an average of 42 days

• 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 Outcomes (8)

• 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

Study Arms (2)

Seidivid Ferty4

EXPERIMENTAL

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).

Dietary Supplement: Seidivid Ferty4

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

Seidivid Ferty4 DIETARY_SUPPLEMENT

The patient will start taking the study treatment (multivitamin supplement with probiotics) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the diatary supplement, without interruption until the day of the GnRH-agonist trigger.

Seidivid Ferty4

Placebo OTHER

The patient will start taking the study treatment (placebo) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the treatment (placebo), without interruption until the day of the GnRH-agonist trigger.

Placebo

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing COH for egg donation cycles
• Signing of Informed Consent
• Age 18-34 years
• Body mass index between 18-29.9 kg/m2
• Ultrasound antral follicle count before COH of ≥15 follicles

You may not qualify if:

• 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

Sponsors & Collaborators

• SEID S.A.: lead

Study Sites (1)

NextFertility

Valencia, 46009, Spain

Location

Related Publications (1)

• Bonta S, Maggi S, Rodriguez R, Jimenez R, Villaquiran AM, Pla E, Fuentes R, Luque MD, Ferrer J, Quintero L. Ovovid trial: the effect of a probiotic micronutrients supplement on oocyte retrieval and quality in oocyte donors. A double blind, randomized controlled trial. J Assist Reprod Genet. 2025 Dec 9. doi: 10.1007/s10815-025-03763-4. Online ahead of print.

  PMID: 41361728 DERIVED

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Results Point of Contact

• Title: Ana Gavilán
• Organization: SEID

agavilan@lab-seid.com

+34 630928812

Study Officials

• Luis Quintero, Ph

  NextFertility Valencia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a dietary supplement with probiotics, with two parallel group of subjects. Based on previous studies, considering this study as a non-inferiority versus placebo study the calculated sample size of subjects is 210 (105 subject for each arm). Once the informed consent is signed, the patient will be assigned a patient code and will be given the treatment box (white and with no label) corresponding to her code. The patient will start taking the study treatment (multivitamin supplement with probiotics or placebo) immediately after inclusion. Throughout the COH period the patient will continue taking the study supplement and will undergo the regular ultrasound controls of the egg donation program for evolutive control of the number and growth of follicles, without interruption until the day of the GnRH-agonist trigger.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 25, 2022
• Study Start: July 11, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 28, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)