Ooxyd: Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

• Sponsor: Clinique Ovo (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05372549
• Collaborator: Ferring Pharmaceuticals (Industry)
• Enrollment: 180
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site: 60
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility Preservation	Other: Oxidative stress; Other: cf-DNA; Other: MAGENTA AI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Evaluation of oocyte quality by visualization [At the end of IVF stimulation]

   Oocyte quality will be measured by MAGENTA AI

2. Assessment of good quality oocytes [IVF stimulation cycle]

   Measurement of serum estradiol levels

3. Number of mature oocytes retrieved [IVF stimulation cycle]

   Efficacy of the combination or Rekovelle and Menopur

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olive Fertility Centre	Vancouver	British Columbia	Canada	V5Z 3X7
2	Ottawa Fertility Centre	Ottawa	Ontario	Canada	K2C 3V4
3	Clinique Ovo	Montreal	Quebec	Canada	H4P 2S4

Sponsors and Collaborators

• Clinique Ovo
• Ferring Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinique Ovo
• ClinicalTrials.gov Identifier: NCT05372549
• Other Study ID Numbers: IIS-1022
• First Posted: May 12, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Aug 5, 2022