Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Study Overview
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Brief Summary
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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.

Official Title
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Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation

Conditions
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Fertility Preservation

Intervention / Treatment
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* Other: Oxidative stress
* Other: cf-DNA
* Other: MAGENTA AI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oncology preservation<br> | Other: Oxidative stress<br>* 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<br>Other: cf-DNA<br>* 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<br>Other: MAGENTA AI<br>* Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality<br>|
| Other: Social (elective) preservation<br> | Other: Oxidative stress<br>* 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<br>Other: cf-DNA<br>* 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<br>Other: MAGENTA AI<br>* Non-invasive technique analyzing images of oocytes that can differentiate oocytes with a higher reproductive potential reflective of their quality<br>|

What is the study measuring?
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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 |