FemaleNCT06203223
The Effect of Ovamax on Oocyte Quality
A study testing Ova-max in people with Female and Infertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Female, Infertility
- What is being tested?
- Ova-max
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2021to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients less than 46 years of age
- ICSI for fertilisation to allow evaluation of oocyte quality
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ovamax on Oocyte Quality in Women Undergoing IVF
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.
Read the detailed description
Randomisation
This study is a blind randomized control trial to evaluate the association between Ova-Max intake and the quality of oocytes retrieved after ovarian stimulation. Randomization will be performed at least three months prior to initiation of treatment and patients will be assigned to either Ova-max or placebo by a computer-generated randomization list.
Ovarian Stimulation
A standard ovarian stimulation protocol for all patients will be followed with 200-300 IU of recombinant FSH and GnRH antagonist starting on day 5 of stimulation.
Induction of final oocyte maturation will be performed by recombinant hCG or GnRH agonist. Women who are planned for fresh embryo transfer, will be administered subcutaneous progesterone for luteal phase support starting on the day of oocyte retrieval.
Oocyte Quality Assessment
After oocyte retrieval the cumulus cells of the Cumulus Oocyte complex (COC) are removed and quality of all mature, metaphase II (MII) oocytes is assessed according to the following parameters:
- Oocyte shape
- Oocyte size
- Ooplasm characteristics
- Structure of the perivitelline space (PVS)
- Zona pellucida (ZP) and
- 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.
The 6 individual parameters are assessed in detail as follows:
- Oocyte shape (-1): poor oocyte morphology (dark general oocyte coloration and/or ovoid shape) (0): almost normal (less dark general oocyte coloration and less ovoid shape) (+1): normal
- Oocyte size (-1): abnormally small or large oocyte (0): almost normal size (+1): oocyte size was within normal range
- Ooplasm characteristics (-1): very granulated and/or very vacuolated cytoplasm and/or demonstrated several inclusions (0): slightly granular and/or demonstrated only few inclusions (+1): absence of granularity and inclusions
- Structure of the perivitelline space (PVS) (-1): abnormally large PVS, absence of PVS or very granular PVS (0): moderately enlarged PVS and/or small PVS and/or a less granular PVS (+1): normal size PVS with no granules
- Zona pellucida (ZP) (-1): very thin or thick ZP (0): small deviation from normal (+1): normal zona
- PB morphology (+1): flat and/or multiple PBs, granular and/or either abnormally small or large PB (0): fair but not excellent PB (+1): normal size and shape of PB
After having assessed the TOS of all MII oocytes, the Mean Oocyte Score (MOS) of the patient is calculated by dividing the sum of all TOS of the patient by the number of her oocytes.
Statistical analysis
Group sample sizes of 79 and 79 achieve 80% power to detect a difference of -1.0 between the null hypothesis that both group TOS means are -1.1 and the alternative hypothesis that the mean TOS of the Ova-Max group is -0.1, with known group standard deviations of 2.2 and 2.2 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform
- Conditions
- Female, Infertility
- Being tested
- Ova-max, placebo
- Keywords
- oocyte quality assessment, oocyte scoring, antioxidants, ivf
- Medical subject headings
- Infertility, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ova-maxOther
use Ova-max 3 months prior to treatment initiation
placeboOther
use placebo 3 months prior to treatment initiation
| Study group | Role | What they receive |
|---|---|---|
| Ova-max | Active comparator | antioxidant, dietary supplement Receives: Other: Ova-max |
| Placebo | Placebo comparator | placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Oocyte shape
- Oocyte size
- Ooplasm characteristics
- Structure of the perivitelline space (PVS)
- Zona pellucida (ZP) and
- 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.
Measured: 1-3 hours after oocyte retrieval
Secondary outcomes (5)
Percentage of mature oocytes
number of mature oocytes of a woman divided by her total oocyte number
Measured: 2-4 hours after oocyte retrieval
Percentage of fertilised oocytes
number of oocytes of a woman that are fertilised divided by the total oocyte injected with sperm
Measured: 16-18 hours after fertilisation
Blastulation rate
the number of embryos that have reached blastocyst stage divided by the number of fertilised oocytes
Measured: day 5 after fertilisation
Pregnancy rate
the number of women who got pregnant divided by the number of women who underwent embryo transfer
Measured: 6 weeks after embryo transfer
Total number of COCs collected
total number of cumulus oocyte complexes collected from each woman
Measured: immediately after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jul 2021
- Primary completion30 Nov 2024
- Study completion15 Jan 2025
Why it stopped: The study was stopped prematurely due to low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Eugonia IVF Unit, Athens, Greece
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
- Investigators
- Efstratios M Kolibianakis, Professor, Principal investigator, Aristotle University Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203223
- Sponsor's protocol ID
- UHR-17
- Status last verified
- May 2025
- First submitted
- 11 Jan 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ovamax on Oocyte Quality in Women Undergoing IVF
- ClinicalTrials.gov ID
- NCT06203223
- Acronym / sponsor ID
- UHR-17
- Conditions
- Female, Infertility
- Keywords
- oocyte quality assessment, oocyte scoring, antioxidants, ivf
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to low recruitment rate
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Eugonia IVF Unit, Athens, Greece
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomisation
This study is a blind randomized control trial to evaluate the association between Ova-Max intake and the quality of oocytes retrieved after ovarian stimulation. Randomization will be performed at least three months prior to initiation of treatment and patients will be assigned to either Ova-max or placebo by a computer-generated randomization list.
Ovarian Stimulation
A standard ovarian stimulation protocol for all patients will be followed with 200-300 IU of recombinant FSH and GnRH antagonist starting on day 5 of stimulation.
Induction of final oocyte maturation will be performed by recombinant hCG or GnRH agonist. Women who are planned for fresh embryo transfer, will be administered subcutaneous progesterone for luteal phase support starting on the day of oocyte retrieval.
Oocyte Quality Assessment
After oocyte retrieval the cumulus cells of the Cumulus Oocyte complex (COC) are removed and quality of all mature, metaphase II (MII) oocytes is assessed according to the following parameters:
- Oocyte shape
- Oocyte size
- Ooplasm characteristics
- Structure of the perivitelline space (PVS)
- Zona pellucida (ZP) and
- 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.
The 6 individual parameters are assessed in detail as follows:
- Oocyte shape (-1): poor oocyte morphology (dark general oocyte coloration and/or ovoid shape) (0): almost normal (less dark general oocyte coloration and less ovoid shape) (+1): normal
- Oocyte size (-1): abnormally small or large oocyte (0): almost normal size (+1): oocyte size was within normal range
- Ooplasm characteristics (-1): very granulated and/or very vacuolated cytoplasm and/or demonstrated several inclusions (0): slightly granular and/or demonstrated only few inclusions (+1): absence of granularity and inclusions
- Structure of the perivitelline space (PVS) (-1): abnormally large PVS, absence of PVS or very granular PVS (0): moderately enlarged PVS and/or small PVS and/or a less granular PVS (+1): normal size PVS with no granules
- Zona pellucida (ZP) (-1): very thin or thick ZP (0): small deviation from normal (+1): normal zona
- PB morphology (+1): flat and/or multiple PBs, granular and/or either abnormally small or large PB (0): fair but not excellent PB (+1): normal size and shape of PB
After having assessed the TOS of all MII oocytes, the Mean Oocyte Score (MOS) of the patient is calculated by dividing the sum of all TOS of the patient by the number of her oocytes.
Statistical analysis
Group sample sizes of 79 and 79 achieve 80% power to detect a difference of -1.0 between the null hypothesis that both group TOS means are -1.1 and the alternative hypothesis that the mean TOS of the Ova-Max group is -0.1, with known group standard deviations of 2.2 and 2.2 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ova-max | Active comparator | Other: Ova-maxantioxidant, dietary supplement |
| Placebo | Placebo comparator | Other: placeboplacebo |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients less than 46 years of age
- ICSI for fertilisation to allow evaluation of oocyte quality
Key exclusion criteria (6 listed)
- Women with endometriosis
- Women with only one ovary
- More than two previous IVF cycles
- Use of testicular sperm
- Intake of other dietary supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ova-maxuse Ova-max 3 months prior to treatment initiation | Other | Ova-max |
| placebouse placebo 3 months prior to treatment initiation | Other | Placebo |
Primary outcome
Mean oocyte score
Time frame: 1-3 hours after oocyte retrieval
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.
5 secondary outcomes
Percentage of mature oocytes
Time frame: 2-4 hours after oocyte retrieval
Percentage of fertilised oocytes
Time frame: 16-18 hours after fertilisation
Blastulation rate
Time frame: day 5 after fertilisation
Pregnancy rate
Time frame: 6 weeks after embryo transfer
Total number of COCs collected
Time frame: immediately after oocyte retrieval
Results and safety
The study was stopped early (reason given: The study was stopped prematurely due to low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efstratios M Kolibianakis, Professor principal investigator
Aristotle University Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ova-max in people with Female and Infertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely due to low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean oocyte score (time frame: 1-3 hours after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.