A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation

NCT ID: NCT02449889

Last Updated: 2019-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-03-01

Brief Summary

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This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HP-hCG IM

highly purified human chorionic gonadotropin, intramuscularly (IM)

Group Type EXPERIMENTAL

highly purified human chorionic gonadotropin

Intervention Type DRUG

HP-hCG SC

highly purified human chorionic gonadotropin, subcutaneously (SC)

Group Type EXPERIMENTAL

highly purified human chorionic gonadotropin

Intervention Type DRUG

rhCG

recombinant human chorionic gonadotropin

Group Type ACTIVE_COMPARATOR

recombinant human chorionic gonadotropin

Intervention Type DRUG

Interventions

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highly purified human chorionic gonadotropin

Intervention Type DRUG

recombinant human chorionic gonadotropin

Intervention Type DRUG

Other Intervention Names

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CHORAPUR BREVACTID OVIDREL OVITRELLE

Eligibility Criteria

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Inclusion Criteria

* Pre-menopausal females between the ages of 18 and 39 years
* Documented history of infertility
* Body mass index (BMI) between 17.5 and 32.0 kg/m2
* Regular menstrual cycles

Exclusion Criteria

* Known endometriosis stage III and IV
* Known polycystic ovarian syndrome (PCOS)
* History of recurrent miscarriage
* History of more than three previous controlled ovarian stimulation cycles
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)

São Paulo, , Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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000191

Identifier Type: -

Identifier Source: org_study_id

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