Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03483545
Other study ID # 000324
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05634850 - Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
Completed NCT03803228 - Dual Ovarian Stimulation (DUOSTIM) for Poor Ovarian Responders Phase 3
Active, not recruiting NCT06053827 - Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)
Recruiting NCT03480412 - Second Step Protocol in Poor Ovarian Responder (POR)
Not yet recruiting NCT04604054 - The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF N/A
Not yet recruiting NCT04606082 - Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI N/A
Not yet recruiting NCT04589793 - COaching Lifestyle Intervention for FErtility N/A
Completed NCT06441409 - Serum Ferritin Levels and Metabolic Dysfunction Associated Steatotic Liver Disease N/A
Completed NCT03846544 - Double Pick up in Poor Prognosis Women Phase 4
Completed NCT04141436 - Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF) N/A
Recruiting NCT05271981 - Fertility After Uterine Artery Embolization
Completed NCT03007043 - Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response
Completed NCT03161873 - Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
Completed NCT04133402 - Fertility After Intrauterine Tamponing Balloon: Where Are we
Active, not recruiting NCT06128395 - ASA 81 mg vs 162 mg During Frozen Embryo Transfer (FET)
Recruiting NCT05807256 - Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
Completed NCT03908697 - Quantum Natural Family Planning Pilot N/A
Completed NCT04908774 - Effects of a Fasting Mimicking Diet on Sperm Quality N/A
Recruiting NCT05205733 - Expanding Fertility Care to Poor and Low Resourced Settings Study N/A
Active, not recruiting NCT03085212 - Strategies for Pregnancy Achievement N/A