Menopur And Rekovelle Combination Study (MARCS)

Dr François Bissonnette

Status

Completed

Conditions

Fertility Disorders

Treatments

Combination Product: Follitropin delta and HP-hMG

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03483545

000324

Details and patient eligibility

About

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.

Full 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

Enrollment

160 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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