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

NCT01152866 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2013-08-06

No results posted yet for this study

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

Interventions

DRUG

Choriogonadotropin alpha (r-hCG)

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

Sponsors & Collaborators

Principal Investigators

  • Horia Ijacu, MD · EMD Serono a division of EMD Canada Inc.

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2004-12-31
Completion
2004-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01152866 on ClinicalTrials.gov