Menopur And Rekovelle Combination Study

Fertility Disorders Clinical Trial

— MARCS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483545
• Other study ID #: 000324
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Combination Product:
• Follitropin delta and HP-hMG
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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec
Canada	CReATe Fertility Centre	Toronto	Ontario
Canada	Hannam Fertility Centre	Toronto	Ontario
Canada	Olive Fertility Centre	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Dr François Bissonnette	Create Fertility Center, Hannam Fertility Centre, Olive Fertility Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 days of embryo culture
Secondary	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	up to 20 days
Secondary	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.	up to 20 days