Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Not Applicable

Completed

• Conditions: Fertility Preservation
• Interventions: Other: Oxidative stress; Other: cf-DNA; Other: MAGENTA AI

• Registration Number: NCT05372549
• Lead Sponsor: Clinique Ovo

Brief 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.

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

Not available

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-12
• Study Start: 2022-06-01
• Primary Completion: 2024-12-18
• Study Completion: 2025-01-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Oncology preservation	MAGENTA AI	-
Social (elective) preservation	MAGENTA AI	-
Oncology preservation	Oxidative stress	-
Oncology preservation	cf-DNA	-
Social (elective) preservation	Oxidative stress	-
Social (elective) preservation	cf-DNA	-

Primary Outcome Measures

Name	Time	Method
Evaluate the correlation between the oxidative stress and the quality of oocytes	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 Outcome Measures

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

Trial Locations

Locations (3)

Olive Fertility Centre; 🇨🇦 Vancouver, British Columbia, Canada

Ottawa Fertility Centre; 🇨🇦 Ottawa, Ontario, Canada

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada