An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)

August 4, 2013 updated by: EMD Serono

An Observational Study Using Subcutaneous Ovidrel (Choriogonadotrophin Alfa) for Induction of Final Follicular Maturation and Early Luteinisation in Women Undergoing Ovarian Stimulation With Recombinant-human Follicle Stimulating Hormone (r-hFSH [Gonal-F®]).

With the development of the recombinant gonadotrophins, the use of human source proteins for the production of hormones has become unnecessary. These proteins, which are found in urinary preparations, have been thought to cause the local, post-injection adverse events (AEs) in some subjects.

There has been a demand by physicians for an alternative to urinary products for treatment. Due to allergies to urinary products, or other personal reasons, subjects were not able or willing to be treated with proteins of human origin. This study allowed subjects to be treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins), which otherwise would not be possible. The study sponsor used this opportunity to collect additional safety data on the new recombinant product, (Ovidrel, r-hCG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately one in ten couples of reproductive age experiences infertility. Infertility may be caused by problems in men, in women or in both. A number of techniques can be used depending on the duration and type of infertility problems. The treatment of ovulation induction (OI) uses the help of exogenous gonadotrophins such as follicle stimulating hormone (FSH), luteinizing hormone (LH) and hCG in order to stimulate follicles and release oocytes for fertilization in the fallopian tubes.

Assisted reproductive technologies (ARTs), including in-vitro fertilization (IVF) and intra- cytoplasmic sperm injection (ICSI), increases the chances of success to obtain more than one embryo. In order to obtain more than one embryo, it is necessary to stimulate the growth and maturation of several follicles. Such a multiple follicular development is obtained by daily administration of a follicle stimulating hormone (r-hFSH, Gonal-F). When these follicles have reached a large enough size, the role of hCG is to achieve final oocyte maturation and initiation of follicular luteinization.

Serono International S.A. has developed a pharmaceutical preparation of human chorionic gonadotrophin (hCG) for clinical use through the application of recombinant DNA technology. The resulting product is choriogonadotrophin alpha, a pure recombinant human chorionic gonadotrophin (r-hCG). The corresponding drug product is marketed under the tradename Ovidrel. Ovidrel (choriogonadotrophin alpha for injection) has been approved in the United States, in the European Union and Australia.

OBJECTIVES The objective of this study was to collect safety information in order to confirm the already known profile of r- hCG (Ovidrel).

Study Type

Observational

Enrollment (Actual)

3

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects desiring pregnancy who had been unable to conceive and been diagnosed by a physician who is familiar with infertility and its monitoring.

Description

Inclusion Criteria:

  • Infertile women desiring a pregnancy
  • Subjects whose baseline hormonal values were within normal ranges as per local practice
  • Subjects who were willing and able to comply with the protocol for the duration of the study
  • Subjects who had given written informed consent, prior to treatment, with the understanding that consent might be withdrawn at any time without prejudice

Exclusion Criteria:

  • Subjects with clinically significant disease
  • Subjects who were known to be infected by human immunodeficiency virus (HIV), Hepatitis B or C
  • Subjects who had any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism or excretion of study drug
  • Subjects with severe endometriosis
  • Subjects with abnormal, undiagnosed gynaecological bleeding
  • Subjects who had any contra-indication to being pregnant or carrying a pregnancy to term
  • Subjects who were pregnant or breast-feeding at the beginning of the cycle. Confirmation that the subject was not pregnant was to be established by a negative urine or serum pregnancy test in the 7 days prior to Study Day1
  • Subjects with prior hypersensitivity to hCG preparations or one of their excipients
  • Subjects with uncontrolled thyroid or adrenal dysfunction
  • Subjects with uncontrolled organic intracranial lesion such as a pituitary tumour
  • Subjects with ovarian cyst or enlargement of undetermined origin
  • Subjects with sex hormone dependent tumors of the reproductive organs and breasts

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment
Time Frame: Pre-treatment screening within 6 weeks prior to beginning GnRH-agonist therapy or stimulation day 1 (S1) to post-treatment period (30 days of the last administration of the investigational product)
Safety of Ovidrel was assessed through the recording, reporting and analysis of baseline medical conditions, adverse events, general physical examination, laboratory tests, and vital signs data.
Pre-treatment screening within 6 weeks prior to beginning GnRH-agonist therapy or stimulation day 1 (S1) to post-treatment period (30 days of the last administration of the investigational product)

Collaborators and Investigators

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

Sponsor

EMD Serono

Investigators

  • Study Director: Horia Ijacu, MD, EMD Serono a division of EMD Canada Inc.

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

December 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24662

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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