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

June 17, 2019 updated by: Ferring Pharmaceuticals

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing 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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP-hCG IM
highly purified human chorionic gonadotropin, intramuscularly (IM)
Drug: highly purified human chorionic gonadotropin
Other Names:
  • CHORAPUR
  • BREVACTID
Experimental: HP-hCG SC
highly purified human chorionic gonadotropin, subcutaneously (SC)
Drug: highly purified human chorionic gonadotropin
Other Names:
  • CHORAPUR
  • BREVACTID
Active Comparator: rhCG
recombinant human chorionic gonadotropin
Drug: recombinant human chorionic gonadotropin
Other Names:
  • OVIDREL
  • OVITRELLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Oocytes Retrieved
Time Frame: Approximately 36 hours after hCG administration
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Approximately 36 hours after hCG administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Metaphase II (MII) Oocytes
Time Frame: Prior to insemination (within 6 hours after oocyte retrieval)
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Prior to insemination (within 6 hours after oocyte retrieval)
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Time Frame: One day after oocyte retrieval
Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.
One day after oocyte retrieval
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Time Frame: 13-15 days after transfer
Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
13-15 days after transfer
Clinical Pregnancy Rate
Time Frame: 5-6 weeks after transfer
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
5-6 weeks after transfer
Frequency of Adverse Events (AEs)
Time Frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Intensity of AEs
Time Frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).
AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

July 9, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on highly purified human chorionic gonadotropin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe