Fertility PreservationOoxydNCT05372549
Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation
A study testing Oxidative stress, cf-DNA and MAGENTA AI in people with Fertility Preservation, run by Clinique Ovo at 3 sites in Canada.
Trial summary
Whether it is for oncology or personal reasons, fertility preservation allows participants to preserve their oocytes (eggs) at their current age and condition for a better chance of having a baby in the future. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Fertility Preservation
- What is being tested?
- Oxidative stress, cf-DNA and MAGENTA AI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jun 2022to 3 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason
Who cannot join
- Pregnancy and lactation
- Uncontrolled thyroid or adrenal dysfunction
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement not due to polycystic ovarian syndrome
- Gynaecological haemorrhages of unknown aetiology
- Endometriosis stage III/IV
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- Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
- Use of Coenzyme Q10 during the stimulation cycle
- Renal and/or hepatic impairment
- Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Clinique Ovo
Montreal, Quebec, H4P 2S4
Ottawa Fertility Centre
Ottawa, Ontario, K2C 3V4
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7
About this study
Whether it is for oncology or personal reasons, fertility preservation allows participants to preserve their oocytes (eggs) at their current age and condition for a better chance of having a baby in the future.
In order to proceed with fertility preservation, participants will need to undergo in vitro fertilization (IVF), which is standard practice, and take stimulation medication to stimulate production of more follicles.
Read more
The combination of both Rekovelle and Menopur for fertility preservation may increase ovarian response to stimulation and increase the number of oocytes retrieved to give better chances of embryos once the oocytes will be fertilized.
The goal in this study is to understand the effect of oxydative stress on the quality of oocytes.
For the purpose of the study and to evaluate this connection, serum levels of oxidative stress and cf-DNA in your blood will be measured.
Oocyte quality will also be assessed with Magenta, a prediction tool utilizing artificial intelligence (AI). This method is non-invasive and has no risks on the oocytes.
- Conditions
- Fertility Preservation
- Being tested
- Oxidative stress, cf-DNA, MAGENTA AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidative stressOther
Oxidative stress occurs as soon as there is an imbalance between pro- / antioxidants, and molecules exhibiting antioxidant properties are at the forefront of fertility treatment and preservation. Oxidated stress will be measured by blood sample
cf-DNAOther
cfDNA, extracted from blood plasma in samples collected will uncover the potential role of cfDNA as a stress signal released in response to oxidative stress
MAGENTA AIOther
Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality
| Study group | Role | What they receive |
|---|---|---|
| Oncology preservation | Other | Not described Receives: Other: Oxidative stress; Other: cf-DNA; Other: MAGENTA AI |
| Social (elective) preservation | Other | Not described Receives: Other: Oxidative stress; Other: cf-DNA; Other: MAGENTA AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation between the oxidative stress and the quality of oocytes
Serum sample measure variations of oxidation-reduction potential (ORP) with MiOXSYS analyzer and by PCR
Measured: Change from baseline oxidative stress at the end of IVF controlled ovarian stimulaition
Secondary outcomes (3)
Evaluation of oocyte quality by visualization
Oocyte quality will be measured by MAGENTA AI
Measured: At the end of IVF stimulation
Assessment of good quality oocytes
Measurement of serum estradiol levels
Measured: IVF stimulation cycle
Number of mature oocytes retrieved
Efficacy of the combination or Rekovelle and Menopur
Measured: IVF stimulation cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Jun 2022
- Primary completion18 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372549
- Sponsor's protocol ID
- IIS-1022
- Acronym
- Ooxyd
- Status last verified
- Mar 2025
- First submitted
- 2 May 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation
- ClinicalTrials.gov ID
- NCT05372549
- Acronym / sponsor ID
- Ooxyd / IIS-1022
- Conditions
- Fertility Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 12 May 2022 (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.
Whether it is for oncology or personal reasons, fertility preservation allows participants to preserve their oocytes (eggs) at their current age and condition for a better chance of having a baby in the future.
In order to proceed with fertility preservation, participants will need to undergo in vitro fertilization (IVF), which is standard practice, and take stimulation medication to stimulate production of more follicles.
The combination of both Rekovelle and Menopur for fertility preservation may increase ovarian response to stimulation and increase the number of oocytes retrieved to give better chances of embryos once the oocytes will be fertilized.
The goal in this study is to understand the effect of oxydative stress on the quality of oocytes.
For the purpose of the study and to evaluate this connection, serum levels of oxidative stress and cf-DNA in your blood will be measured.
Oocyte quality will also be assessed with Magenta, a prediction tool utilizing artificial intelligence (AI). This method is non-invasive and has no risks on the oocytes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncology preservation | Other | Other: Oxidative stress, Other: cf-DNA, Other: MAGENTA AI |
| Social (elective) preservation | Other | Other: Oxidative stress, Other: cf-DNA, Other: MAGENTA AI |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason
Key exclusion criteria (10 listed)
- Pregnancy and lactation
- Uncontrolled thyroid or adrenal dysfunction
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement not due to polycystic ovarian syndrome
- Gynaecological haemorrhages of unknown aetiology
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 |
|---|---|---|
| Oxidative stressOxidative stress occurs as soon as there is an imbalance between pro- / antioxidants, and molecules exhibiting antioxidant properties are at the forefront of fertility treatment and preservation. Oxidated stress will be measured by blood sample | Other | Oncology preservation, Social (elective) preservation |
| cf-DNAcfDNA, extracted from blood plasma in samples collected will uncover the potential role of cfDNA as a stress signal released in response to oxidative stress | Other | Oncology preservation, Social (elective) preservation |
| MAGENTA AINon-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality | Other | Oncology preservation, Social (elective) preservation |
Primary outcome
Evaluate the correlation between the oxidative stress and the quality of oocytes
Time frame: Change from baseline oxidative stress at the end of IVF controlled ovarian stimulaition
Serum sample measure variations of oxidation-reduction potential (ORP) with MiOXSYS analyzer and by PCR
3 secondary outcomes
Evaluation of oocyte quality by visualization
Time frame: At the end of IVF stimulation
Assessment of good quality oocytes
Time frame: IVF stimulation cycle
Number of mature oocytes retrieved
Time frame: IVF stimulation cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxidative stress, cf-DNA and MAGENTA AI in people with Fertility Preservation, run by Clinique Ovo at 3 sites in Canada.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the correlation between the oxidative stress and the quality of oocytes (time frame: Change from baseline oxidative stress at the end of IVF controlled ovarian stimulaition). 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 Mar 2025.