Correlation of Oxidative Stress and Oocyte Quality in Fertility Preservation (Ooxyd)

Ovo Clinic

Status: Completed

Conditions: Fertility Preservation

Treatments: Other: MAGENTA AI; Other: Oxidative stress; Other: cf-DNA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372549

IIS-1022

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

Oncology preservation

Other group

Treatment:

Other: cf-DNA

Other: Oxidative stress

Other: MAGENTA AI

Social (elective) preservation

Other group

Treatment:

Other: cf-DNA

Other: Oxidative stress

Other: MAGENTA AI