Infertility and at High Risk of OHSSNCT02022228
Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
A study testing triptorelin and hCG in people with Infertility and at High Risk of OHSS, run by Chenshiling at 1 site in China.
Trial summary
Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Infertility and at High Risk of OHSS
- What is being tested?
- triptorelin and hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jun 2016
- Phase
- Interventional
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with polycystic ovarian syndrome
- patients with polycystic ovarian morphology on ultrasound
- patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins
Who cannot join
- patients undergoing coasting
- patients with past ovarian surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Shi-Ling Chen, M.D., Ph.D., +86-20-62787604, chensl_92@163.com
Shi-Ling Chen, M.D., Ph.D.
About this study
Official title: Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.
However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.
Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.
- Conditions
- Infertility and at High Risk of OHSS
- Being tested
- triptorelin, hCG
- Keywords
- Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity, Gonadotropin Releasing Hormone Agonist, Human Chorionic Gonadotropin
- Medical subject headings
- Infertility, Ovarian Hyperstimulation Syndrome, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triptorelinDrug
Also called triptorelin: Diphereline
0.2 mg triptorelin, ih
hCGDrug
1000 IU hCG, im
hCGDrug
500IU hCG, im
| Study group | Role | What they receive |
|---|---|---|
| 0.2mg triptorelin and 500 IU hCG | Experimental | Patients were triggered with 0.2mg triptorelin and 500 IU hCG Receives: Drug: triptorelin; Drug: hCG |
| 0.2mg triptorelin and 1000 IU hCG | Experimental | Patients were triggered with 0.2mg triptorelin and 1000 IU hCG Receives: Drug: triptorelin; Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate per transfer cycle
Measured: 1month post embryo transfer
numbers of patients having OHSS
Measured: 2 weeks post trigger with dual GnRHa
oocyte yield
Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.
Measured: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
Oocyte maturity
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).
Measured: 24 hours post oocyte retrieval day
Secondary outcomes (4)
serum luteinizing hormone level 12 hours post trigger
Measured: 12 hours post trigger
serum hCG level 12 hours post trigger
Measured: 12 hours post trigger
fertilization rate
Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization (i.e. the denominator in IVF in calculating fertilization rate is all oocytes recovered, but in ICSI it is calculated using only the number of MII oocytes).
Measured: 48 hours post IVF/ICSI
implantation rate
Measured: 1 month post embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility and at High Risk of OHSSStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chenshiling
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science, Guangzhou Science and Technology Program key projects, National Key Research and Development Program of China
- Responsible party
- Sponsor-investigator, Chenshiling, Nanfang Hospital, Southern Medical University
- Investigators
- Shi-Ling Chen, M.D., Ph.D., Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022228
- Sponsor's protocol ID
- Dual Trigger
- Status last verified
- Oct 2013
- First submitted
- 15 Dec 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
- ClinicalTrials.gov ID
- NCT02022228
- Acronym / sponsor ID
- Dual Trigger
- Conditions
- Infertility and at High Risk of OHSS
- Keywords
- Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity, Gonadotropin Releasing Hormone Agonist, Human Chorionic Gonadotropin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ChenshilingUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science, Guangzhou Science and Technology Program key projects, National Key Research and Development Program of China
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Dec 2013 (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.
Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.
However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.
Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2mg triptorelin and 500 IU hCG | Experimental | Drug: triptorelin, Drug: hCGPatients were triggered with 0.2mg triptorelin and 500 IU hCG |
| 0.2mg triptorelin and 1000 IU hCG | Experimental | Drug: triptorelin, Drug: hCGPatients were triggered with 0.2mg triptorelin and 1000 IU hCG |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with polycystic ovarian syndrome
- patients with polycystic ovarian morphology on ultrasound
- patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins
Key exclusion criteria (2 listed)
- patients undergoing coasting
- patients with past ovarian surgery
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 |
|---|---|---|
| triptorelinAlso: triptorelin: Diphereline0.2 mg triptorelin, ih | Drug | 0.2mg triptorelin and 1000 IU hCG, 0.2mg triptorelin and 500 IU hCG |
| hCG1000 IU hCG, im | Drug | 0.2mg triptorelin and 1000 IU hCG |
| hCG500IU hCG, im | Drug | 0.2mg triptorelin and 500 IU hCG |
Primary outcome
clinical pregnancy rate per transfer cycle
Time frame: 1month post embryo transfer
numbers of patients having OHSS
Time frame: 2 weeks post trigger with dual GnRHa
oocyte yield
Time frame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.
Oocyte maturity
Time frame: 24 hours post oocyte retrieval day
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).
4 secondary outcomes
serum luteinizing hormone level 12 hours post trigger
Time frame: 12 hours post trigger
serum hCG level 12 hours post trigger
Time frame: 12 hours post trigger
fertilization rate
Time frame: 48 hours post IVF/ICSI
implantation rate
Time frame: 1 month post embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
Shi-Ling Chen, M.D., Ph.D. study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triptorelin and hCG in people with Infertility and at High Risk of OHSS, run by Chenshiling at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Dec 2013. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi-Ling Chen, M.D., Ph.D. (+86-20-62787604, chensl_92@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate per transfer cycle (time frame: 1month post embryo transfer). The study lists 4 primary outcomes in all. 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 27 Dec 2013.