Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Fertility Preservation Clinical Trial

— Ooxyd  

Official title:

Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372549
• Other study ID #: IIS-1022
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Clinique Ovo
• Contact: Nelly Delouya, RN
• Phone: 514.798.2000
• Email: n.delouya[@]cliniqueovo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Preservation

Intervention

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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec
Canada	Ottawa Fertility Centre	Ottawa	Ontario
Canada	Olive Fertility Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Ovo	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

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