SubfertilityPhase 2ATDNCT01973842
Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients
A Phase 2 study testing 0.1 mg triptorelin, 0.2 mg triptorelin and 0.4 mg triptorelin in people with Subfertility, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- 0.1 mg triptorelin, 0.2 mg triptorelin and 0.4 mg triptorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGreece
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- Endometriosis > than grade II
- One ovary
Trial locations and contacts
2 sites in 1 country.
Efstratios Kolilbianakis, MD, MSc, PhD contact
Georgios Lainas, MD contact
Greece2 sites, 2 recruiting
- Recruiting
Eugonia IVF Unit
Athens
Trifon Lainas, MD, PhD, tlainas@otenet.gr
Trifon Lainas, MD, PhD
- Recruiting
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki
Efstratios Kolibianakis, MD, MSc, PhD, stratis.kolibianakis@gmail.com
Efstratios Kolibianakis, MD, MSc, PhD
About this study
Official title: Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients Undergoing Ovarian Stimulation for IVF With GnRH Antagonists and Recombinant FSH.
The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.
Read the detailed description
Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.
Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.
Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.
- Conditions
- Subfertility
- Being tested
- 0.1 mg triptorelin, 0.2 mg triptorelin, 0.4 mg triptorelin
- Keywords
- GnRH agonist, OHSS, Triggering final oocyte maturation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 mg triptorelinDrug
0.2 mg triptorelinDrug
0.4 mg triptorelinDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.2 mg triptorelin | Active comparator | 0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin Receives: Drug: 0.2 mg triptorelin |
| 0.1 mg triptorelin | Active comparator | 0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin Receives: Drug: 0.1 mg triptorelin |
| 0.4 mg triptorelin | Active comparator | 0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin Receives: Drug: 0.4 mg triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mature oocytes retrieved
Percentage of mature oocytes retrieved following oocyte retrieval
Measured: 36 hours post GnRH agonst administration
Secondary outcomes (6)
total number of oocytes retrieved
Measured: 36 hours post GnRH agonist administration
oocyte recovery rate
Measured: 36 hours post GnRH agonist administration
Fertilization rate
Measured: Day 1 post oocyte retrieval
Serum LH, FSH, E2, PRG levels
Measured: 8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
Duration of luteal phase
Measured: 16 days
OHSS occurrence
Occurrence of ovarian hyperstimulation syndrome
Measured: 16 days post triggering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Eugonia IVF Unit, Athens, Greece
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
- Investigators
- Efstratios Kolibianakis, MD, MSc, PhD, Principal investigator, Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973842
- Sponsor's protocol ID
- Agonist triggering dose
- Acronym
- ATD
- Status last verified
- Feb 2016
- First submitted
- 25 Oct 2013
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients Undergoing Ovarian Stimulation for IVF With GnRH Antagonists and Recombinant FSH.
- ClinicalTrials.gov ID
- NCT01973842
- Acronym / sponsor ID
- ATD / Agonist triggering dose
- Conditions
- Subfertility
- Keywords
- GnRH agonist, OHSS, Triggering final oocyte maturation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Eugonia IVF Unit, Athens, Greece
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Nov 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.
The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.
Detailed description
Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.
Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.
Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.2 mg triptorelin | Active comparator | Drug: 0.2 mg triptorelin0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin |
| 0.1 mg triptorelin | Active comparator | Drug: 0.1 mg triptorelin0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin |
| 0.4 mg triptorelin | Active comparator | Drug: 0.4 mg triptorelin0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Endometriosis > than grade II
- One ovary
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 |
|---|---|---|
| 0.1 mg triptorelin | Drug | 0.1 mg triptorelin |
| 0.2 mg triptorelin | Drug | 0.2 mg triptorelin |
| 0.4 mg triptorelin | Drug | 0.4 mg triptorelin |
Primary outcome
Percentage of mature oocytes retrieved
Time frame: 36 hours post GnRH agonst administration
Percentage of mature oocytes retrieved following oocyte retrieval
6 secondary outcomes
total number of oocytes retrieved
Time frame: 36 hours post GnRH agonist administration
oocyte recovery rate
Time frame: 36 hours post GnRH agonist administration
Fertilization rate
Time frame: Day 1 post oocyte retrieval
Serum LH, FSH, E2, PRG levels
Time frame: 8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
Duration of luteal phase
Time frame: 16 days
OHSS occurrence
Time frame: 16 days post triggering
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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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.
Efstratios Kolilbianakis, MD, MSc, PhD contact
Georgios Lainas, MD contact
Efstratios Kolibianakis, MD, MSc, PhD principal investigator
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.1 mg triptorelin, 0.2 mg triptorelin and 0.4 mg triptorelin in people with Subfertility, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 0 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Efstratios Kolilbianakis, MD, MSc, PhD (stratis.kolibianakis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of mature oocytes retrieved (time frame: 36 hours post GnRH agonst administration). 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 12 Feb 2016.