NCT05372549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

May 2, 2022

Last Update Submit

March 17, 2025

Conditions

Fertility Preservation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluation of oocyte quality by visualization

    At the end of IVF stimulation

  • Assessment of good quality oocytes

    IVF stimulation cycle

  • Number of mature oocytes retrieved

    IVF stimulation cycle

Study Arms (2)

Oncology preservation

OTHER
Other: Oxidative stressOther: cf-DNAOther: MAGENTA AI

Social (elective) preservation

OTHER
Other: Oxidative stressOther: cf-DNAOther: MAGENTA AI

Interventions

Oxidative stressOTHER

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

Oncology preservationSocial (elective) preservation
cf-DNAOTHER

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

Oncology preservationSocial (elective) preservation
MAGENTA AIOTHER

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

Oncology preservationSocial (elective) preservation

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing fertility preservation for oncology or social purposes
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Women 18 to 37 years of age inclusively eligible for fertility preservation for either social or oncology reason

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Olive Fertility Centre

Vancouver, British Columbia, V5Z 3X7, Canada

Location

Ottawa Fertility Centre

Ottawa, Ontario, K2C 3V4, Canada

Location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Interventions

Oxidative Stress

Intervention Hierarchy (Ancestors)

MetabolismStress, PhysiologicalPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 12, 2022

Study Start

June 1, 2022

Primary Completion

December 18, 2024

Study Completion

January 3, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)