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Completed

NCT Number: NCT03483545

Menopur And Rekovelle Combination Study

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.

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Key information

Conditions

Fertility Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Olive Fertility Centre, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follitropin delta and HP-hMG

Combination Product

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Dr François Bissonnette

Industry

Collaborators

  • Create Fertility Center
  • Hannam Fertility Centre
  • Olive Fertility Centre

Registry information

Official study title

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)

Acronym: MARCS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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