A Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Fina… (NCT01081756) | Clinical Trial Compass
CompletedPhase 3
A 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)
China218 participantsStarted 2003-12
Plain-language summary
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.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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