Follitropin Delta + HP-hMG for In Vitro Fertilization

(MARCS 2 Trial)

Recruiting at 1 trial location

Overseen By Marya Far

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Clinique Ovo

Must not be taking: Hormonal preparations

Disqualifiers: Endometriosis III/IV, OHSS risk, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is: - Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ? Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes Participants will: * Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight * Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels * Undergo standard IVF procedures including egg retrieval and embryo assessment

Eligibility Criteria

This trial is for women aged 18 to 40 who are undergoing IVF. It's designed for those seeking a personalized ovarian stimulation regimen. Participants must meet certain health criteria, but specific inclusion and exclusion details aren't provided.

Inclusion Criteria

Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 and Day 5 of menstrual cycle within the previous 24 months

First IVF/ICSI cycle

Partner or donor ejaculated sperm (fresh or frozen) used for fertilization

Exclusion Criteria

Women undergoing oocyte donation

Body Mass Index (BMI) > 40 kg/m2

Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Stimulation

Participants receive ovarian stimulation using a personalized dose of REKOVELLE and MENOPUR based on age and weight

2 weeks

Multiple visits for ultrasound imaging and blood tests

IVF Procedures

Participants undergo standard IVF procedures including egg retrieval and embryo assessment

1 week

1 visit for egg retrieval and embryo assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of OHSS risk

2 weeks

1-2 visits for follow-up assessments

Treatment Details

Interventions

• Combination therapy: Follitropin delta and HP-hMG

Trial Overview The study tests if personalizing doses of REKOVELLE (follitropin delta) and MENOPUR (HP-hMG) based on age and body weight leads to effective IVF outcomes compared to previous methods using AMH levels and weight.

Participant Groups

Group I: Follitropin delta and HP-hMG Experimental Treatment 1 Intervention

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