Completed

NCT Number: NCT01718119

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

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

Completed

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Key information

Conditions

Hyperovulation Induction for Assisted Reproduction Treatment

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cha Medical school Boondang-Cha hospital, Seongnam, Gyeong-Gi Do, South Korea

About this study

This is an single-blind, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of final follicle maturation and early luteinization in 180 Korean female subjects undergoing superovulation. The study is organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both groups receives a single injection of hCG when the follicular development was judged to be adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro. Not more than 4 embryos are to be replaced. Progesterone is administered daily according to center's normal practice, starting after the oocyte pick up and continuing until appropriate time. The subject is followed up and the treatment outcome (negative pregnancy test or pregnancy) is recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-hCG

Drug

r-hCG(250mcg) injection subcutaneously

Primary outcomes

the efficacy and safety of DA-3803(r-hCG)

Time frame: about 1 month after ART

the number of oocytes retrieved per patient following r-hCG administration, physical examination, clinical laboratory measurements, adverse events, injection-sited reactions, OHSS, number of multiple pregnancies

Secondary outcomes

the efficacy of DA-3803(r-hCG)

Time frame: about 1 month after ART

number of patients who received r-hCG with at least one oocyte retrieved, number of oocyte retrieved per number of follicles >10mm diameter on the day of r-hCG, number of mature oocytes, number of 2PN fertilized oocytes, number of 2PN cleaved embryos, implantation rate per embryo transferred, number of biochemical and clinical pregnancies

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase III Clinical Trial Comparing the Efficacy and Safety of DA-3803(Recombinant Human Chorionic Gonadotrophin) and Ovidrel for Inducting Final Follicular Maturation and Early Luteinization in Women Undergoing Ovulation

Acronym: DA-3803

Important dates

Study start: 2012
Primary completion: 2013
First posted: Oct 31, 2012
Registry last updated: Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.