Menopur And Rekovelle Combination Study (MARCS)

August 27, 2019 updated by: Dr François Bissonnette

An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)

This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3X7
        • Olive Fertility Centre
    • Ontario
      • Toronto, Ontario, Canada, M4W 3R2
        • Hannam Fertility Centre
      • Toronto, Ontario, Canada, M5G 1N8
        • Create Fertility Centre
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique ovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
  • Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
  • Regular menstrual cycles of 24-35 days
  • Presence of both ovaries
  • Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
  • Ejaculated sperm (fresh or frozen) for insemination

Exclusion Criteria:

  • Inability to consent
  • Endometriosis stage III and IV
  • High risk of OHSS (AMH ≥ 35 pmol/L)
  • History of recurrent miscarriages defined as ≥ 3 consecutive losses
  • Women undergoing egg donation
  • Women participating in any other research project
  • Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
  • Hypersensitivity to follitropin delta and/or HP-hMG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follitropin delta and HP-hMG
Follitropin delta combined with highly purified human menopausal gonadotrophin
Combination product: Follitropin delta and HP-hMG
Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
Time Frame: 6 days of embryo culture
Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer
6 days of embryo culture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine dosage of REKOVELLE and Menopur in a mixed protocol
Time Frame: up to 20 days
Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation
up to 20 days
Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm
Time Frame: up to 20 days
The safety profile is the proportion of women with early and late OHSS and/or preventive interventions for early OHSS (i.e., triggering with GnRH agonist, use of dopamine agonist, conversion of planned fresh transfer into a freeze-all). OHSS is defined as an iatrogenic complication that occurs mainly due to ovarian overstimulation by gonadotropins.
up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr François Bissonnette

Collaborators

Create Fertility Center
Olive Fertility Centre
Hannam Fertility Centre

Investigators

  • Principal Investigator: François Bissonnette, MD, Clinique ovo
  • Principal Investigator: Clifford Librach, MD, Create Fertility Centre
  • Principal Investigator: Tom Hannam, MD, Hannam Fertility Centre
  • Principal Investigator: Al Yuzpe, MD, Olive Fertility Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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