Follitropin Delta + HP-hMG for In Vitro Fertilization

(MARCS 2 Trial)

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to personalizing IVF (in vitro fertilization) treatments using two medications, REKOVELLE (follitropin delta) and MENOPUR (HP-hMG). The researchers aim to determine if adjusting doses based on age and body size is as effective as the current method, which uses hormone levels and weight. Participants will undergo standard IVF procedures, including egg retrieval and embryo assessment. Women with unexplained infertility, certain types of infertility, or mild endometriosis, who have regular menstrual cycles and are undergoing their first IVF cycle, may be suitable for the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in personalized IVF care.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using hormonal medications, except for certain ones like 17β-estradiol, testosterone gel, DHEA, and thyroid medication, during the last menstrual cycle before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using follitropin delta and HP-hMG together is generally well-tolerated. This combination effectively stimulates the ovaries. Notably, follitropin delta is associated with a lower risk of ovarian hyperstimulation syndrome (OHSS), where the ovaries become swollen and painful, compared to traditional treatments like follitropin alfa or beta.

In these studies, personalized dosing of follitropin delta and HP-hMG has resulted in a significant number of usable embryos. This indicates that the treatment is both effective and safe for many patients. While all medications can have side effects, existing research strongly suggests that this combination is generally safe for use in IVF procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Follitropin delta and HP-hMG are exciting in the realm of in vitro fertilization (IVF) because they offer a new approach by combining two different types of hormonal stimulation. Unlike standard IVF treatments that typically rely on a single gonadotropin, this combination therapy uses Follitropin delta, a recombinant follicle-stimulating hormone, alongside HP-hMG, which contains both FSH and LH activities. This dual action might enhance ovarian response more effectively. Researchers are hopeful that this approach could improve outcomes for patients undergoing IVF by optimizing the hormonal environment for egg development.

What evidence suggests that this trial's treatments could be effective for IVF?

Research has shown that using follitropin delta and HP-hMG together can improve IVF results. One study found that this combination produced a good number of usable embryos by days 5 and 6. Other findings suggest that this approach balances benefits and risks effectively. Additionally, similar pregnancy and live birth rates occurred with different medications, including follitropin delta and HP-hMG, even when the number of eggs retrieved varied. Overall, the evidence supports the potential effectiveness of personalized dosing of these medications in IVF treatment. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38817059/

Clinical outcomes of ovarian stimulation with follitropin ... The present study provides a first glimpse into the favourable benefit: risk profile of a mixed protocol regimen using follitropin delta combined with HP-hMG.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0015028220324006

Individualized ovarian stimulation for in vitro fertilization: a ... A mixed protocol of individualized dosing of follitropin delta and HP-hMG resulted in a statistically significant number of usable blastocysts on days 5 and 6 ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/results/NCT05103228

Cumulative Pregnancy Rate With Lower and Higher ... Low-dose group: 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG); 10 mcg follitropin delta + 75 IU hpHMG.

4. e-mjm.org e-mjm.org/2024/v79n3/ovarian-stimulation.pdf

Clinical outcomes of ovarian stimulation with follitropin ... In this study, we aimed to assess the efficacy of an ovarian stimulation protocol employing a personalised dosing algorithm for a novel ...

5. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.70014

The Type of Follicle‐Stimulating Hormone Medication Given ... Fertilization, pregnancy, and live birth rates were similar across the medications, despite differences in the number of retrieved oocytes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33267959/

Individualized ovarian stimulation for in vitro fertilization A mixed protocol of individualized dosing of follitropin delta and HP-hMG resulted in a statistically significant number of usable blastocysts on days 5 and 6 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05873725?term=follitropin&rank=5

Retrospective Study of High Dose Follitropin Delta in a ... Follitropin delta + HP-hMG. Combination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined ...

8. ovarianresearch.biomedcentral.com ovarianresearch.biomedcentral.com/articles/10.1186/s13048-024-01372-w

Efficacy and safety of follitropin delta for ovarian stimulation in ... Personalized follitropin delta treatment is associated with a lower risk of OHSS compared to conventional follitropin alfa/beta administration.