Infertility Clinical Trial
Official title:
An Open, Randomized, Comparative Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
Verified date | March 2010 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.
Status | Completed |
Enrollment | 218 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Infertility regular ovulatory menstrual cycles; - Early luteal phase serum levels: - FSH= 10IU/l - LH= 10IU/l - PRL= 30ng/ml - T= 50pg/ml - Haematology, blood chemistry, urinalysis normal - Both ovaries present - < 3 previous ART cycles, no ART cycles for 2 menstrual cycles Exclusion Criteria: - With a poor response to gonadotrophin stimulation, such as =3 oocytes collected in any previous IVF cycle - Any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug. - Had previous severe ovarian hyperstimulation syndrome(OHSS) - A body mass index (BMI) >25 kg/m2 - Any contraindication to being pregnant and/or carrying a pregnancy to term - Extra-uterine pregnancy within the last 3 months - A clinically significant systemic disease - Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus - Abnormal gynaecological bleeding of undetermined origin - Known allergy or hypersensitivity to human gonadotrophin preparations - Simultaneous participation in another clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Peking University 3rd Hopistal | Beijing |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocyte retrieved | 36 hrs after hCG administration | Yes |
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