An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

July 30, 2014 updated by: Merck KGaA, Darmstadt, Germany

A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI

This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Follicle stimulating hormone (FSH) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. The technical advance of recombinant technology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. These developments have enabled recombinant human FSH follitropin alfa (Gonal-F) to be filled and released in vials on the basis of mass with a variability of only ±2%. In one study, the FbM batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. In another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. The authors concluded that the pen device of Gonal-F is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form.

This prospective, multicentric, observational study is planned in women using Gonal-F FbM in ovarian hyperstimulation as part of their IVF/ICSI treatment at infertility clinics in Korea. Subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects).

OBJECTIVES

Primary objective:

  • To assess the effectiveness Gonal-F FbM

Secondary objectives:

  • To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months

Study Type

Observational

Enrollment (Actual)

1539

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for the study.

Description

Inclusion Criteria:

  • Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study

Exclusion Criteria:

  • Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the excipients
  • Subjects with tumors of the hypothalamus and pituitary gland
  • Ovarian enlargement or cyst not due to polycystic ovarian disease
  • Gynecological hemorrhages of unknown etiology
  • Ovarian, uterine or mammary carcinoma
  • Primary ovarian failure
  • Malformations of sexual organs incompatible with pregnancy
  • Fibroid tumors of the uterus incompatible with pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Start of treatment to confirmation of pregnancy
Number of oocytes retrieved and clinical pregnancy rate per cycle
Start of treatment to confirmation of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy, Safety and Convenience
Time Frame: Start of treatment to confirmation of pregnancy

Secondary efficacy parameters includes total Gonal-f dose; stimulation profile of IVF cycle; number of follicles > 14 mm on day of hCG; number of available embryos; pregnancy status (hCG test, ultrasound exam); on the day of embryo transfer (ET).

Convenience and safety parameters includes subject convenience rated by completing a questionnaire, local tolerance assessment (local reactions at the injection site, pain, satisfaction and convenience)
Start of treatment to confirmation of pregnancy

Collaborators and Investigators

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

Sponsor

Merck KGaA, Darmstadt, Germany

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, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (ESTIMATE)

February 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 700623_507

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.

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