Status:
COMPLETED
An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)
Lead Sponsor:
EMD Serono
Conditions:
Ovulation Induction
Infertility
Eligibility:
FEMALE
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,...
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 dur...
Eligibility Criteria
Inclusion
- 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- Subjects who had given written informed consent, prior to treatment, with the understanding that consent might be withdrawn at any time without prejudice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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01152866
Start Date
December 1 2003
End Date
December 1 2004
Last Update
August 6 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.