Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation (Ooxyd)

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 Overview

• Status: Recruiting
• Conditions: Fertility Preservation
• Intervention / Treatment: Other: Oxidative stress; Other: cf-DNA; Other: MAGENTA AI

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nelly Delouya, RN; Phone Number: 759 514.798.2000; Email: n.delouya@cliniqueovo.com
• Study Contact Backup: Name: Marion Vivien, PhD; Phone Number: 624 514.798.2000; Email: m.vivien@cliniqueovo.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 3X7
      • Not yet recruiting
      • Olive Fertility Centre
      • Contact: Amy Malone, RN; Phone Number: 604.559.9950; Email: amalone@olivefertility.com
      • Principal Investigator: Albert Yuzpe, MD
  • Ontario
    • Ottawa, Ontario, Canada, K2C 3V4
      • Not yet recruiting
      • Ottawa Fertility Centre
      • Contact: Jennifer McDowall, CCRC; Phone Number: 620 613.686.3378; Email: jmcdowall@conceive.ca
      • Principal Investigator: Jenna Gale, MD
  • Quebec
    • Montreal, Quebec, Canada, H4P 2S4
      • Recruiting
      • Clinique OVO
      • Contact: Nelly Delouya, RN; Phone Number: 759 514.798.2000; Email: n.delouya@cliniqueovo.com
      • Contact: Marion Vivien, PhD; Phone Number: 627 514.798.2000; Email: m.vivien@cliniqueovo.com
      • Principal Investigator: Isaac-Jacques Kadoch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oncology preservation	Other: 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; 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; Other: MAGENTA AI; Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality
Other: Social (elective) preservation	Other: 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; 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; Other: MAGENTA AI; Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline oxidative stress at the end of IVF controlled ovarian stimulaition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of oocyte quality by visualization	Oocyte quality will be measured by MAGENTA AI	At the end of IVF stimulation
Assessment of good quality oocytes	Measurement of serum estradiol levels	IVF stimulation cycle
Number of mature oocytes retrieved	Efficacy of the combination or Rekovelle and Menopur	IVF stimulation cycle

Collaborators and Investigators

• Sponsor: Clinique Ovo
• Collaborators: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IIS-1022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No