Menopur And Rekovelle Combination Study

Dr François Bissonnette160 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Fertility Disorders

Interventions

Follitropin delta and HP-hMGCOMBINATION_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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (4)

Olive Fertility Centre

Vancouver, British Columbia, Canada

Hannam Fertility Centre

Toronto, Ontario, Canada

CReATe Fertility Centre

Toronto, Ontario, Canada

Clinique Ovo

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: 6 days of embryo culture

Secondary Outcomes

Determine dosage of REKOVELLE and Menopur in a mixed protocol

Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation

Time frame: up to 20 days

Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm

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.

Time frame: up to 20 days

Data from ClinicalTrials.gov

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