Menopur And Rekovelle Combination Study

Not Applicable

Completed

• Conditions: Fertility Disorders
• Interventions: Combination Product: Follitropin delta and HP-hMG

• Registration Number: NCT03483545
• Lead Sponsor: Dr François Bissonnette

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.

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 Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2018-07-17
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follitropin delta and HP-hMG	Follitropin delta and HP-hMG	Follitropin delta combined with highly purified human menopausal gonadotrophin

Primary Outcome Measures

Name	Time	Method
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture	6 days of embryo culture	Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer

Secondary Outcome Measures

Name	Time	Method
Determine dosage of REKOVELLE and Menopur in a mixed protocol	up to 20 days	Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation
Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm	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.

Trial Locations

Locations (4)

Hannam Fertility Centre; 🇨🇦 Toronto, Ontario, Canada

CReATe Fertility Centre; 🇨🇦 Toronto, Ontario, Canada

Olive Fertility Centre; 🇨🇦 Vancouver, British Columbia, Canada

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada