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

Not Applicable

Completed

• Conditions: Reproductive Techniques, Assisted

• Registration Number: NCT05473039
• Lead Sponsor: SEID S.A.

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 Timeline

• Study First Submitted: 2022-06-27
• Study Start: 2022-07-11
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Primary Completion: 2024-07-01
• Status Verified: 2024-12
• Study Completion: 2024-12-28
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Baseline fasting glucose	Baseline	Fasting blood glucose at the time of study inclusion
Rate of oocytes with dimorphisms	Through study completion, an average of 42 days	Percentage of mature oocytes MII with dimorphisms respect to the total mature oocytes MII retrieved
Baseline AST	Baseline	Serum aspartate aminotransferase (AST) levels at the time of study inclusion
Number of antral follicles at study inclusion	Baseline	Ultrasound antral follicle count at study inclusion
Number of antral follicles at the time of COH start	Through COH start, an average of 30 days	Ultrasound antral follicle count at the time of controlled ovarian hyperstimulation (COH) start
Fasting glucose at the time of COH start	Through COH start, an average of 30 days	Fasting blood glucose at the time of controlled ovarian hyperstimulation (COH) start
Rate of oocytes with extra-cytoplasmic dimorphisms	Through study completion, an average of 42 days	Percentage of mature oocytes MII with extra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved
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
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
Rate of normal or good quality oocytes	Through study completion, an average of 42 days	Percentage of mature oocytes MII without dimorphisms respect to the total mature oocytes MII retrieved
Cholesterol at the time of COH start	Through COH start, an average of 30 days	Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start
Rate of oocytes with intra-cytoplasmic dimorphisms	Through study completion, an average of 42 days	Percentage of mature oocytes MII with intra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved
AST at the time of COH start	Through COH start, an average of 30 days	Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start
Baseline ALT	Baseline	Serum alanine aminotransferase (ALT) levels at the time of study inclusion
Baseline Cholesterol	Baseline	Total cholesterol at the time of study inclusion
ALT at the time of COH start	Through COH start, an average of 30 days	Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start

Trial Locations

Locations (1)

NextFertility; 🇪🇸 Valencia, Spain