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

NCT01152866 | Completed

• 1 other identifier: 24662
• Study Type: observational
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Ovulation Induction; Infertility

Keywords

Multifollicular stimulation; Pregnancy; Reproductive Techniques, Assisted; Fertilization in Vitro; Infertility

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  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)

Interventions

Choriogonadotropin alpha (r-hCG) DRUG

Choriogonadotropin alpha 250 μg was administered subcutaneously on the day following the last dose of follitropin alpha (Gonal-F).

Also known as: Ovidrel

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

Chorionic Gonadotropin; Ovidrel

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Horia Ijacu, MD

  EMD Serono a division of EMD Canada Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: December 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: August 6, 2013

Record last verified: 2013-08