Menopur And Rekovelle Combination Study Version 2.0

NCT06997900 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-31

No results posted yet for this study

Summary

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

Conditions

  • IVF
  • Controlled Ovarian Simulation
  • Fertility Disorders

Interventions

DRUG

Combination therapy : Follitropin delta and HP-hMG

Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY
  • Clinique Ovo

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-04
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997900 on ClinicalTrials.gov