Ovarian Hyperstimulation SyndromePhase 4NCT01714648
Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
A Phase 4 study testing Triptorelin 0.2 mg in people with Ovarian Hyperstimulation Syndrome, run by Elisha Hospital at 1 site in Israel.
Trial summary
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Triptorelin 0.2 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Jan 2014
- Phase
- Phase 4
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A female patient who needs IVF to become pregnant.
- Regular menstrual cycle.
- Antral follicular count (AFC) > 18
- Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.
Who cannot join
- Hypersensitivity to the active substance or to any of the medications used.
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- Pregnancy.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure.
- Ovarian cysts or enlarged ovaries.
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- A history of Ovarian Hyperstimulation Syndrome (OHSS).
- A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination.
- Fibroid tumours of the uterus incompatible with pregnancy.
- Malformations of the reproductive organs incompatible with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
Read the detailed description
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Triptorelin 0.2 mg
- Keywords
- OVULATION INDUCTION
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin 0.2 mgDrug
Also called Decapeptyl 0.2 mg
A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| OHSS high risk patients | Experimental | Triptorelin 0.2 mg Receives: Drug: Triptorelin 0.2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
Measured: 12 day from GnRH agonist trigger day.
Secondary outcomes (1)
Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.
Measured: One month from embryo transfer date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisha Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Dr. Shahar Kol, Elisha Hospital
- Investigators
- Shahar Kol, MD, Principal investigator, Elisha Hospital, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714648
- Sponsor's protocol ID
- MSD-ELISHA1
- Other IDs
- 8328-086
- Status last verified
- Aug 2015
- First submitted
- 20 Oct 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
- ClinicalTrials.gov ID
- NCT01714648
- Acronym / sponsor ID
- MSD-ELISHA1
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OVULATION INDUCTION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Elisha HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 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.
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
Detailed description
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHSS high risk patients | Experimental | Drug: Triptorelin 0.2 mgTriptorelin 0.2 mg |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A female patient who needs IVF to become pregnant.
- Regular menstrual cycle.
- Antral follicular count (AFC) > 18
- Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance or to any of the medications used.
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- Pregnancy.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure.
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 |
|---|---|---|
| Triptorelin 0.2 mgAlso: Decapeptyl 0.2 mgA single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval. | Drug | OHSS high risk patients |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
Time frame: 12 day from GnRH agonist trigger day.
OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
1 secondary outcome
Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.
Time frame: One month from embryo transfer date
Results and safety
The study was stopped early (reason given: Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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.
Shahar Kol, MD principal investigator
Elisha Hospital, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptorelin 0.2 mg in people with Ovarian Hyperstimulation Syndrome, run by Elisha Hospital at 1 site in Israel.
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 10 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: stopped early, as of the sponsor's last update on 4 Aug 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated). Results are not available in the source record.
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 Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval. (time frame: 12 day from GnRH agonist trigger day.). 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 4 Aug 2015.