Drug Combination for Fertility Preservation

(Ooxyd Trial)

Recruiting at 1 trial location

Overseen By Jenna Gale, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Clinique Ovo

Must be taking: Stimulation medication

Must not be taking: Hormonal preparations, Coenzyme Q10

Disqualifiers: Pregnancy, Endometriosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

179 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for women aged 18-37 who are looking to preserve their fertility for personal or medical reasons. It's not suitable for pregnant or breastfeeding women, those with certain hormonal disorders, advanced endometriosis, unexplained bleeding issues, kidney/liver problems, or allergies to the medications used.

Inclusion Criteria

I am a woman aged 18-37 seeking fertility preservation for personal or cancer-related reasons.

Exclusion Criteria

I have kidney or liver problems.

My tumor is located in the hypothalamus or pituitary gland.

My thyroid or adrenal glands are not functioning properly and are not controlled.

Treatment Details

Interventions

• Menopur
• Rekovelle

Trial Overview The study tests how oxidative stress affects egg quality during fertility preservation. Participants will undergo IVF and take Rekovelle and Menopur to stimulate follicle production. Blood levels of oxidative stress and cf-DNA will be measured; AI tool Magenta assesses oocyte quality non-invasively.

Participant Groups

Group I: Social (elective) preservation Experimental Treatment 3 Interventions

Group II: Oncology preservation Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Clinique Ovo

Lead Sponsor

Trials

33

Recruited

41,600+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science