In Vitro FertilizationNCT02477566
Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI
A study testing Long-acting Triptorelin and Short-acting Triptorelin in people with In Vitro Fertilization and Polycystic Ovary Syndrome, run by Nanjing University at 1 site in China.
Trial summary
To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization, Polycystic Ovary Syndrome
- What is being tested?
- Long-acting Triptorelin and Short-acting Triptorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 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 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment
Who cannot join
- Patients with poor ovarian reserve,
- immunological disease,
- endometriosis,
- uterine abnormality,
- endometrium thickness < 8mm before embryo transfer,
- fewer than two good-quality embryos available for transfer or patients with inadequate data for analysis were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital
Nanjing, Jiangsu, 210008
Jianjun Zhou, Dcotor, 86-25-83304616-70014, zhou6jj@hotmail.com
About this study
Official title: Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment
To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection
Read the detailed description
All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely. The long-acting Triptorelin group use long-acting Triptorelin 1.875mg during the luteal phase on Pituitary down-regulation , the Short acting Triptorelin use short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase. Gonadotrophin stimulation of the ovaries was started when serum E2 concentrations declined to < 40 pg/ml and a vaginal ultrasonographic scan showed an absence of follicles > 10mm diameter. Ovarian stimulation was started wih 150-250 IU/day of recombinant FSH (Gonal F, Serono, Switzerland); the initial dose was determined by clinical judgement of the clinician according to the patients's age, body mass index, basal FSH and E2. Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly. Ovulation was triggered by intramuscular administration of 5000-10,000 IU of human chorionic gonadotropin (HCG, Ferring Pharmaceuticals) when at least two follicles reached a diameter of 18 mm. Serum HCG value were measured at 12 h after HCG trigger using the immunoassay. Oocytes were retrieved 36 h after the injection of HCG.
- Conditions
- In Vitro Fertilization, Polycystic Ovary Syndrome
- Being tested
- Long-acting Triptorelin, Short-acting Triptorelin
- Keywords
- pcos, Long acting Triptorelin, Short acting Triptorelin, In Vitro Fertilization
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting TriptorelinDrug
Also called Long-acting Triptorelin on pituitary down-regulation
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase
Short-acting TriptorelinDrug
Also called Short-acting Triptorelin on pituitary down-regulation
Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase
| Study group | Role | What they receive |
|---|---|---|
| Long-acting Triptorelin | Experimental | Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal Receives: Drug: Long-acting Triptorelin |
| Short-acting Triptorelin | Active comparator | Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase Receives: Drug: Short-acting Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment
Measured: 2 years
Secondary outcomes (1)
moderate/severe OHSS rate
compare the moderate/severe OHSS rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477566
- Sponsor's protocol ID
- BL2014003
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment
- ClinicalTrials.gov ID
- NCT02477566
- Acronym / sponsor ID
- BL2014003
- Conditions
- In Vitro Fertilization, Polycystic Ovary Syndrome
- Keywords
- pcos, Long acting Triptorelin, Short acting Triptorelin, In Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 23 Jun 2015 (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.
To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection
Detailed description
All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely. The long-acting Triptorelin group use long-acting Triptorelin 1.875mg during the luteal phase on Pituitary down-regulation , the Short acting Triptorelin use short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase. Gonadotrophin stimulation of the ovaries was started when serum E2 concentrations declined to < 40 pg/ml and a vaginal ultrasonographic scan showed an absence of follicles > 10mm diameter. Ovarian stimulation was started wih 150-250 IU/day of recombinant FSH (Gonal F, Serono, Switzerland); the initial dose was determined by clinical judgement of the clinician according to the patients's age, body mass index, basal FSH and E2. Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly. Ovulation was triggered by intramuscular administration of 5000-10,000 IU of human chorionic gonadotropin (HCG, Ferring Pharmaceuticals) when at least two follicles reached a diameter of 18 mm. Serum HCG value were measured at 12 h after HCG trigger using the immunoassay. Oocytes were retrieved 36 h after the injection of HCG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-acting Triptorelin | Experimental | Drug: Long-acting TriptorelinPituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal |
| Short-acting Triptorelin | Active comparator | Drug: Short-acting TriptorelinPituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment
Key exclusion criteria (6 listed)
- Patients with poor ovarian reserve,
- immunological disease,
- endometriosis,
- uterine abnormality,
- endometrium thickness < 8mm before embryo transfer,
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 |
|---|---|---|
| Long-acting TriptorelinAlso: Long-acting Triptorelin on pituitary down-regulationPituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase | Drug | Long-acting Triptorelin |
| Short-acting TriptorelinAlso: Short-acting Triptorelin on pituitary down-regulationPituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase | Drug | Short-acting Triptorelin |
Primary outcome
Clinical pregnancy rate
Time frame: 2 years
compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment
1 secondary outcome
moderate/severe OHSS rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-acting Triptorelin and Short-acting Triptorelin in people with In Vitro Fertilization and Polycystic Ovary Syndrome, run by Nanjing University 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 1 inclusion and 6 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 23 Jun 2015. 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 Jianjun Zhou, Doctor (86-25-83304616-70014, zhou6jj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 2 years). 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 23 Jun 2015.