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)
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)
1 other identifier
interventional
218
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedJuly 31, 2014
March 1, 2010
March 4, 2010
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of oocyte retrieved
36 hrs after hCG administration
Study Arms (2)
Subjects treated with r-hCG
EXPERIMENTALSubjects treated with r-hCG
Subjects treated with urinary hCG
ACTIVE COMPARATORSubjects treated with urinary hCG
Interventions
r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
Urinary hCG (10,000 IU) injection s.c. or i.m.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University 3rd Hopistal
Beijing, 100191, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huafei Li
Serono Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
December 1, 2003
Study Completion
September 1, 2004
Last Updated
July 31, 2014
Record last verified: 2010-03