InfertilityPhase 3NCT01402336
GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer
A Phase 3 study testing GnRH antagonist (Cetrorelix) and Conventional GnRH agonist (Triptorelin) in people with Infertility and Polycystic Ovary Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovary Syndrome
- What is being tested?
- GnRH antagonist (Cetrorelix) and Conventional GnRH agonist (Triptorelin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to 31 Dec 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
- age 20-40 years
- patients who have normal uterus
- Korean ethnicity
Who cannot join
- patients who have abnormal thyroid function
- patients who have abnormal prolactin test
- patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
- Patients who reject informed consent
- patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET
GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.
Read the detailed description
GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol
- Conditions
- Infertility, Polycystic Ovary Syndrome
- Being tested
- GnRH antagonist (Cetrorelix), Conventional GnRH agonist (Triptorelin)
- Keywords
- Polycystic ovary syndrome, ovulation induction, In vitro fertilization-embryo transfer
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonist (Cetrorelix)Drug
Also called Cetrotide
In the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation
Conventional GnRH agonist (Triptorelin)Drug
Also called Decapeptyl
Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist, SD #1 starting group | Experimental | Start GnRH antagonist from stimulation day 1 during ovulation induction cycles Receives: Drug: GnRH antagonist (Cetrorelix) |
| GnRH antagonist, SD #6 starting group | Experimental | Start GnRH antagonist from stimulation day 6 during ovulation induction cycles Receives: Drug: GnRH antagonist (Cetrorelix) |
| Conventional GnRH agonist long group | Active comparator | Conventional GnRH agonist long protocol Receives: Drug: Conventional GnRH agonist (Triptorelin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocyte retrieved
Measured: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible.
Secondary outcomes (1)
pregnancy rate
Measured: after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJun 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Min Choi, Seoul National University Hospital
- Investigators
- Young Min Choi, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402336
- Sponsor's protocol ID
- PCOS_IVF
- Status last verified
- Oct 2017
- First submitted
- 4 Jul 2011
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET
- ClinicalTrials.gov ID
- NCT01402336
- Acronym / sponsor ID
- PCOS_IVF
- Conditions
- Infertility, Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, ovulation induction, In vitro fertilization-embryo transfer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 26 Jul 2011 (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.
GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.
Detailed description
GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist, SD #1 starting group | Experimental | Drug: GnRH antagonist (Cetrorelix)Start GnRH antagonist from stimulation day 1 during ovulation induction cycles |
| GnRH antagonist, SD #6 starting group | Experimental | Drug: GnRH antagonist (Cetrorelix)Start GnRH antagonist from stimulation day 6 during ovulation induction cycles |
| Conventional GnRH agonist long group | Active comparator | Drug: Conventional GnRH agonist (Triptorelin)Conventional GnRH agonist long protocol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
- age 20-40 years
- patients who have normal uterus
- Korean ethnicity
Key exclusion criteria (5 listed)
- patients who have abnormal thyroid function
- patients who have abnormal prolactin test
- patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
- Patients who reject informed consent
- patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).
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 |
|---|---|---|
| GnRH antagonist (Cetrorelix)Also: CetrotideIn the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation | Drug | GnRH antagonist, SD #1 starting group, GnRH antagonist, SD #6 starting group |
| Conventional GnRH agonist (Triptorelin)Also: DecapeptylPatients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive. | Drug | Conventional GnRH agonist long group |
Primary outcome
number of oocyte retrieved
Time frame: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible.
1 secondary outcome
pregnancy rate
Time frame: after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.
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 10 Oct 2017.
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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.
Young Min Choi, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GnRH antagonist (Cetrorelix) and Conventional GnRH agonist (Triptorelin) in people with Infertility and Polycystic Ovary Syndrome, run by Seoul National University Hospital at 1 site 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 4 inclusion and 5 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 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
number of oocyte retrieved (time frame: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible.). 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 10 Oct 2017.