NCT04416607

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

May 26, 2020

Last Update Submit

June 1, 2020

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

corifollitropin alpha

EXPERIMENTAL

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

menotropin

ACTIVE COMPARATOR

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

Interventions

Corifollitropin AlfaDRUG

Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.

Also known as: Elonva® (Schering-Plough)
corifollitropin alpha
MenotropinsDRUG

Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.

Also known as: Menopur® (Ferring)
menotropin

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Reproduçao Humana Insemine

Porto Alegre, RGS, 90001003, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, RGS, 90003051, Brazil

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptideMenotropins

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Joao Sabino Lahorgue da Cunha Filho, Ph.D.

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

June 15, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)