Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel for inducting final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment

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

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Treatments: Chorionic Gonadotropin

Criteria

Inclusion Criteria:

• Infertility regular ovulatory menstrual cycles : 25~35days

• BMI<=30kg/m2

• Early follicular phase serum levels are normal : FSH, LH, prolactin, testosterone

• Both ovaries present and clinically normal uterine cavity

• < 3 previous ART cycles, no ART cycles for 2 menstrual cycles

• semen analysis and ART are possible

• informed couple consent

Exclusion Criteria:

• With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous ART cycle

• Had previous severe ovarian hyperstimulation syndrome(OHSS)

• Polycystic ovarian syndrome(PCOS)

• Extra-uterine pregnancy within the last 3 months

• A clinically significant uncontrolled endocrine diseases, chronic cardiovascular disorders, hepatic, pulmonary and renal diseases

• Known allergy,hypersensitivity or contraindication to FSH, hCG, progesterone and GnRH antagonists

• medication with human gonadotrophin preparations(FSH, LH, hCG) within 2 months

• participation in another clinical trial within 1 month