Drug Combination for Fertility Preservation
(Ooxyd Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining Rekovelle and Menopur can help women preserve more high-quality eggs for future use. The researchers aim to determine if this combination improves ovarian response, potentially leading to the retrieval of more eggs during IVF. The study also examines the impact of oxidative stress (a type of cell damage) on egg quality. It is suitable for women aged 18 to 37 considering fertility preservation for personal or medical reasons, such as cancer treatment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in fertility preservation.
Will I have to stop taking my current medications?
The trial requires that you stop using hormonal medications (except for thyroid medication) during the last menstrual cycle and Coenzyme Q10 during the stimulation cycle.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Menopur and Rekovelle are generally well-tolerated treatments for fertility preservation. Menopur stimulates the ovaries to produce more eggs and is commonly used in fertility treatments. Studies indicate it is safe when administered by experienced doctors, though it can have side effects like any medication.
Rekovelle, another fertility drug, has a safety profile similar to other treatments. Research has found it carries a lower risk of causing ovarian hyperstimulation syndrome (OHSS), a condition that can occur when the ovaries are overstimulated.
Both Menopur and Rekovelle have approval for fertility treatments in many countries, reflecting confidence in their safety. However, participants should consult their doctors about possible side effects and their health conditions to make an informed decision.12345Why are researchers excited about this trial?
Unlike the standard fertility preservation methods, which often rely on hormonal stimulation protocols, the combination of Menopur and Rekovelle offers a unique approach. Researchers are excited because Menopur contains both FSH and LH, potentially providing a more balanced hormonal environment, while Rekovelle uses a new recombinant technology to deliver FSH. This combination may improve the efficiency and outcomes of ovarian stimulation, making it particularly promising for those undergoing fertility preservation for oncology or elective reasons.
What evidence suggests that the combination of Rekovelle and Menopur could be effective for fertility preservation?
This trial will evaluate the use of Rekovelle and Menopur in various contexts for fertility preservation. Studies have shown that using Rekovelle and Menopur together can enhance ovarian response during fertility treatments, potentially leading to the collection of more eggs and increasing the chances of creating a successful embryo. Research also suggests that this combination could improve embryo quality, resulting in higher pregnancy rates. The approach considers the impact of oxidative stress on egg quality, which is crucial for fertility. Initial findings are promising for women seeking to preserve their fertility for medical or personal reasons.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
IVF Stimulation
Participants undergo in vitro fertilization (IVF) and take stimulation medication to stimulate production of more follicles. The combination of Rekovelle and Menopur is used to increase ovarian response.
Oocyte Retrieval and Assessment
Oocytes are retrieved and assessed for quality using Magenta AI. Serum levels of oxidative stress and cf-DNA are measured.
Follow-up
Participants are monitored for safety and effectiveness after oocyte retrieval and assessment.
What Are the Treatments Tested in This Trial?
Interventions
- Menopur
- Rekovelle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clinique Ovo
Lead Sponsor
Ferring Pharmaceuticals
Industry Sponsor
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