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OpenTrials
Completed

NCT Number: NCT05372549

Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

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.

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Key information

Conditions

Fertility Preservation

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Olive Fertility Centre, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxidative stress

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

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of oocyte quality by visualization

    Time frame: At the end of IVF stimulation

    Oocyte quality will be measured by MAGENTA AI

  2. Assessment of good quality oocytes

    Time frame: IVF stimulation cycle

    Measurement of serum estradiol levels

  3. Number of mature oocytes retrieved

    Time frame: IVF stimulation cycle

    Efficacy of the combination or Rekovelle and Menopur

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Collaborators

  • Ferring Pharmaceuticals

Registry information

Acronym: Ooxyd

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 12, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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