Menopur And Rekovelle Combination Study Version 2.0
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorClinique Ovo
About 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 does not accept healthy volunteersQualifiers
Women aged 18 to 40 years inclusively at the time of consent form signature
Diagnosis of unexplained infertility, tubal infertility, endometriosis stage I/II or male factor infertility
Regular menstrual cycles of 24-35 days
Presence of both ovaries
Disqualifiers
Women undergoing oocyte donation
Endometriosis stage III/IV
High risk of OHSS (AMH ≥ 35 pmol/L)
Body Mass Index (BMI) > 40 kg/m2 Protocol number: IIS-1056 MARCS 2.0 Study Version: 1.1 - Date : 14 APR 2025 Page 12 of 28
Trial design
Design model
Single group
Treatments tested in this trial
Combination therapy : Follitropin delta and HP-hMG
DrugFollitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Follitropin delta and HP-hMGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
number of good quality (>3BB) or utilizable blastocysts per treatment cycle at day 5 or 6 of embryo culture
Time frame
5 to 6 days after egg retrieval (up to 1 to 2 months after enrollment)Secondary outcomes
1
Safety profile of follitropin delta + HP-hMG mixed protocol
Patient rate that will develop ovarian hyperstimulation syndrome (OHSS)
Time frame
up to 15 days after egg retrievalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinique Ovo
Lead sponsor
Ferring Pharmaceuticals
Collaborator
Source ClinicalTrials.gov