Hyperovulation Induction for Assisted Reproduction TreatmentPhase 3DA-3803NCT01718119
Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
A Phase 3 study testing r-hCG in people with Hyperovulation Induction for Assisted Reproduction Treatment, run by Dong-A Pharmaceutical Co., Ltd. at 3 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Hyperovulation Induction for Assisted Reproduction Treatment
- What is being tested?
- r-hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2012to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Cha Medical school Boondang-Cha hospital
Seongnam, Gyeong-Gi Do
Cha Medical school Gangnam-Cha hospital
Seoul
Kwandong university medical school Cheil hospital
Seoul
About this study
Official 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
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
Read the detailed description
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.
- Being tested
- r-hCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-hCGDrug
r-hCG(250mcg) injection subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| DA-3803 | Experimental | subjects treated with DA-3803(r-hCG) Receives: Drug: r-hCG |
| Ovidrel | Active comparator | subjects treated with Ovidrel(r-hCG) Receives: Drug: r-hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy and safety of DA-3803(r-hCG)
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
Measured: about 1 month after ART
Secondary outcomes (1)
the efficacy of DA-3803(r-hCG)
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
Measured: about 1 month after ART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperovulation Induction for Assisted Reproduction TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TaeGi Yoon, MD, Study chair, Cha Medical school Gangnam-Cha hospitalDongHee Choi, MD, Principal investigator, Cha Medical school Boondang-Cha hospitalMiKyoung Goong, MD, Principal investigator, Kwandong university medical school Cheil hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718119
- Sponsor's protocol ID
- DA3803_HCG_III
- Acronym
- DA-3803
- Status last verified
- Aug 2013
- First submitted
- 5 Feb 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01718119
- Acronym / sponsor ID
- DA-3803 / DA3803_HCG_III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-3803 | Experimental | Drug: r-hCGsubjects treated with DA-3803(r-hCG) |
| Ovidrel | Active comparator | Drug: r-hCGsubjects treated with Ovidrel(r-hCG) |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| r-hCGr-hCG(250mcg) injection subcutaneously | Drug | DA-3803, Ovidrel |
Primary outcome
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
1 secondary outcome
the efficacy of DA-3803(r-hCG)
Time frame: about 1 month after ART
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TaeGi Yoon, MD study chair
Cha Medical school Gangnam-Cha hospital
DongHee Choi, MD principal investigator
Cha Medical school Boondang-Cha hospital
MiKyoung Goong, MD principal investigator
Kwandong university medical school Cheil hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing r-hCG in people with Hyperovulation Induction for Assisted Reproduction Treatment, run by Dong-A Pharmaceutical Co., Ltd. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy and safety of DA-3803(r-hCG) (time frame: about 1 month after ART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.