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)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Chorionic Gonadotropin

Criteria

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