Clinical trial NCT03483545: Menopur And Rekovelle Combination Study
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Keywords: Ovarian Response
In vitro fertilization
Controlled ovarian stimulation
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
Collaborators: name: Create Fertility Center
name: Olive Fertility Centre
name: Hannam Fertility Centre
First posted: 2018-03-30
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
timeFrame: 6 days of embryo culture
Secondary outcomes:
measure: Determine dosage of REKOVELLE and Menopur in a mixed protocol
timeFrame: up to 20 days
measure: Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm
timeFrame: up to 20 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Olive Fertility Centre
state: British Columbia
city: Toronto
country: Canada
facility: Hannam Fertility Centre
state: Ontario
city: Toronto
country: Canada
facility: CReATe Fertility Centre
state: Ontario
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: François Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CReATe Fertility Centre
name: Clifford Librach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannam Fertility Centre
name: Tom Hannam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Olive Fertility Centre
name: Al Yuzpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.