Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

NCT ID: NCT05372549

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertility Preservation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oncology preservation

Group Type OTHER

Oxidative stress

Intervention Type OTHER

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-DNA

Intervention Type OTHER

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 AI

Intervention Type OTHER

Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality

Social (elective) preservation

Group Type OTHER

Oxidative stress

Intervention Type OTHER

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-DNA

Intervention Type OTHER

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 AI

Intervention Type OTHER

Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxidative stress

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

Intervention Type OTHER

cf-DNA

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

Intervention Type OTHER

MAGENTA AI

Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Olive Fertility Centre

Vancouver, British Columbia, Canada

Site Status

Ottawa Fertility Centre

Ottawa, Ontario, Canada

Site Status

Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIS-1022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ubiquinone vs. Ubiquinol Supplementation
NCT06555575 RECRUITING PHASE2
PMA-FERTITHEQUE Biocollection
NCT05599724 TERMINATED
Inovium Ovarian Rejuvenation Trials
NCT03178695 COMPLETED PHASE1