Corifollitropin Alpha and Ovarian Response

Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)

Objective: To study whether an administration of corifollitropin alpha modifies the follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60kg) or 150 μg (≥60kg) corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in group 2 (n=150).

Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Corifollitropin Alfa; Drug: Menotropins

Detailed Description

Patients will be allocated for convenience into two groups: those who would receive corifollitropin alpha (Group 1) or HMG (Group 2).

Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1, which could be followed by daily administration of HMG beginning on day 8 if necessary; in group 2 150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) will be administered, starting on cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm). Doses will be adjusted as needed by the patient according to the ultrasound, which is performed with a 6 MHz multifrequency transvaginal probe (Toshiba, Japan). The criterion for HCG administration (5.000 IU Choriomon, Biopharma, Brazil) will be at least three follicles greater than 17 mm, and then, 36 hours later, transvaginal oocyte retrieval was performed. After 3 or 5 days, one or two good-quality embryos will be transferred. It will be performed intracytoplasmic sperm injection (ICSI) instead of conventional IVF when major male factor is presented.

Primary outcome measure is FORT. Secondary outcome measures include number of oocytes retrieved, MII, duration of stimulation, number of embryos, embryo quality and clinical pregnancy rate. Adverse events, such as ovarian hyperstimulation syndrome (OHSS) or drug-related complications are also monitored.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RGS
    • Porto Alegre, RGS, Brazil, 90001003
      • Centro de Reproduçao Humana Insemine
    • Porto Alegre, RGS, Brazil, 90003051
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Regular menstrual cycles;
• Body mass index (BMI) of <33.0 kg/m².

Exclusion Criteria:

• Previous ovarian surgery;
• Current diagnosis of polycystic ovarian syndrome (PCOS) or other endocrinopathies;
• History of autoimmune or metabolic disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: corifollitropin alpha; Ovarian stimulation protocol is performed with a single dose of 100 μg (<60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil), plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm).	Drug: Corifollitropin Alfa; Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.; Other Names: Elonva® (Schering-Plough)
ACTIVE_COMPARATOR: menotropin; 150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) is administered, starting on cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm).	Drug: Menotropins; Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.; Other Names: Menopur® (Ferring)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FORT	FORT is calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG × 100/small antral follicle (3 -8 mm in diameter) count at baseline	15 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Joao Sabino Lahorgue da Cunha Filho, Ph.D., Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Menotropins
• Other Study ID Numbers: 87020518800005327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No