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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT01152866
First received: June 28, 2010
Last updated: August 4, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Ovulation Induction
Infertility
Drug: Choriogonadotropin alpha (r-hCG)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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®]).

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples With DNA

Blood samples


Enrollment: 3
Study Start Date: December 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Choriogonadotropin alpha (r-hCG)
    Choriogonadotropin alpha 250 μg was administered subcutaneously on the day following the last dose of follitropin alpha (Gonal-F).
    Other Name: Ovidrel
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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152866

Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Horia Ijacu, MD EMD Serono a division of EMD Canada Inc.
  More Information

No publications provided

Responsible Party: Irene Kavanagh/Medical Research Manager, EMD Serono a division of EMD Canada Inc.
ClinicalTrials.gov Identifier: NCT01152866     History of Changes
Other Study ID Numbers: 24662
Study First Received: June 28, 2010
Last Updated: August 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by EMD Serono:
Multifollicular stimulation
Pregnancy
Reproductive Techniques, Assisted
Fertilization in Vitro
Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Follicle Stimulating Hormone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 20, 2014