Menopur And Rekovelle Combination Study
MARCS
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)
1 other identifier
interventional
160
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
March 30, 2018
CompletedStudy Start
First participant enrolled
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedAugust 28, 2019
August 1, 2019
1 year
March 8, 2018
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer
6 days of embryo culture
Secondary Outcomes (2)
Determine dosage of REKOVELLE and Menopur in a mixed protocol
up to 20 days
Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm
up to 20 days
Study Arms (1)
Follitropin delta and HP-hMG
EXPERIMENTALFollitropin delta combined with highly purified human menopausal gonadotrophin
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr François Bissonnettelead
- Create Fertility Centercollaborator
- Olive Fertility Centrecollaborator
- Hannam Fertility Centrecollaborator
Study Sites (4)
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7, Canada
Hannam Fertility Centre
Toronto, Ontario, M4W 3R2, Canada
CReATe Fertility Centre
Toronto, Ontario, M5G 1N8, Canada
Clinique Ovo
Montreal, Quebec, H4P 2S4, Canada
Related Publications (1)
Bissonnette F, Minano Masip J, Kadoch IJ, Librach C, Sampalis J, Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil Steril. 2021 Apr;115(4):991-1000. doi: 10.1016/j.fertnstert.2020.09.158. Epub 2020 Nov 30.
PMID: 33267959DERIVED
MeSH Terms
Interventions
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2018
First Posted
March 30, 2018
Study Start
July 17, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08