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

Reproductive Techniques, Assisted Clinical Trial

— OvoVid  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473039
• Other study ID #: OVOVID-FERTY4-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: December 28, 2024

Study information

• Verified date: September 2023
• Source: SEID S.A.
• Contact: Ana Gavilan
• Phone: +34938445730
• Email: agavilan[@]lab-seid.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 28, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

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

Related Conditions & MeSH terms

• Reproductive Techniques, Assisted

Intervention

Dietary Supplement:
• Seidivid Ferty4
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Spain	NextFertility	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
SEID S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	Total number of oocytes retrieved in the follicular puncture	Through study completion, an average of 42 days
Primary	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	Rate of normal or good quality oocytes	Percentage of mature oocytes MII without dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Secondary	Rate of oocytes with dimorphisms	Percentage of mature oocytes MII with dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Secondary	Rate of oocytes with intra-cytoplasmic dimorphisms	Percentage of mature oocytes MII with intra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Secondary	Rate of oocytes with extra-cytoplasmic dimorphisms	Percentage of mature oocytes MII with extra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Secondary	Number of antral follicles at study inclusion	Ultrasound antral follicle count at study inclusion	Baseline
Secondary	Number of antral follicles at the time of COH start	Ultrasound antral follicle count at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Secondary	Number of follicles at the time of trigger administration	Ultrasound follicle count at the time of trigger administration	Through trigger administration, an average of 40 days
Secondary	Baseline fasting glucose	Fasting blood glucose at the time of study inclusion	Baseline
Secondary	Fasting glucose at the time of COH start	Fasting blood glucose at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Secondary	Baseline AST	Serum aspartate aminotransferase (AST) levels at the time of study inclusion	Baseline
Secondary	AST at the time of COH start	Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Secondary	Baseline ALT	Serum alanine aminotransferase (ALT) levels at the time of study inclusion	Baseline
Secondary	ALT at the time of COH start	Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Secondary	Baseline Cholesterol	Total cholesterol at the time of study inclusion	Baseline
Secondary	Cholesterol at the time of COH start	Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Secondary	LH at the time of COH start	Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days