The Effect of Ovamax on Oocyte Quality

NCT06203223 | Terminated DMC

• 1 other identifier: UHR-17
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Oocyte quality is a basic parameter that affects embryo quality and therefore it influences the outcome of assisted reproduction. It has been suggested that oocyte quality is improved by the intake of vitamins and antioxidants. Ova-Max is a dietary supplement that consists of vitamins, minerals and antioxidants which improve women's oocytes by preventing oxidative stress. Specifically, Ovamax includes Chasteberry, Melatonin, Myo-Inositol, Folic Acid, Co-Enzyme Q10, Vitamin E, L-Arginine, Grape seed extract and Alpha-lipoic Acid. The purpose of this study is to evaluate the influence of Ova-max intake on oocyte quality in women undergoing In Vitro Fertilization. According to the research hypothesis the administration of Ova-Max for three months increases oocyte quality in women undergoing intracellular sperm injection after ovarian stimulation and oocyte retrieval.

Conditions

Female; Infertility

Keywords

oocyte quality assessment; oocyte scoring; antioxidants; ivf

Outcome Measures

Primary Outcomes (1)

• Mean oocyte score

  The sum of the total oocyte scores of the patient divided by the number of her oocytes. Oocytes is assessed according to the following parameters: 1. Oocyte shape 2. Oocyte size 3. Ooplasm characteristics 4. Structure of the perivitelline space (PVS) 5. Zona pellucida (ZP) and 6. Polar body (PB) morphology Each parameter is graded as worst (-1), average (0), or best (1) and a total oocyte score (TOS) is calculated by summing up individual parameter assessments. The maximal TOS of an oocyte, therefore, could be +6, the lowest -6.

  1-3 hours after oocyte retrieval

Secondary Outcomes (5)

• Percentage of mature oocytes

  2-4 hours after oocyte retrieval

• Percentage of fertilised oocytes

  16-18 hours after fertilisation

• Blastulation rate

  day 5 after fertilisation

• Pregnancy rate

  6 weeks after embryo transfer

• Total number of COCs collected

  immediately after oocyte retrieval

Study Arms (2)

Ova-max

ACTIVE COMPARATOR

antioxidant, dietary supplement

Other: Ova-max

Placebo

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

Ova-max OTHER

use Ova-max 3 months prior to treatment initiation

Ova-max

placebo OTHER

use placebo 3 months prior to treatment initiation

Placebo

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients less than 46 years of age
• ICSI for fertilisation to allow evaluation of oocyte quality

You may not qualify if:

• Women with endometriosis
• Women with only one ovary
• More than two previous IVF cycles
• Use of testicular sperm
• Intake of other dietary supplements
• Poor responders

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Eugonia IVF Unit, Athens, Greece: collaborator

Study Sites (1)

Papageorgiou Hospital

Thessaloniki, Central Macedonia, 54631, Greece

Location

MeSH Terms

Conditions

Infertility; Long Qt Syndrome 3

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Efstratios M Kolibianakis, Professor

  Aristotle University Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: use of placebo, masked randomisation list
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics Gynaecology and Assisted Reproduction

Model Details: randomised controlled trial

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 12, 2024
• Study Start: July 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: January 15, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)