OHSS (Ovarian Hyperstimulation)Phase 4NCT00627406
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
A Phase 4 study testing Buserelin and Pregnyl and Pregnyl in people with OHSS (Ovarian Hyperstimulation), run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- OHSS (Ovarian Hyperstimulation)
- What is being tested?
- Buserelin and Pregnyl and Pregnyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient complying with the conditions for IVF or ICSI treatment
- Female age over 20 years and under 40 years
- Normal regular cycle and patients with oligomenorrhea
- BMI > 18 and < 35
- each patient contributes with one cycle only
Who cannot join
- Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
- Patients with > 25 follicles on the day of triggering ovulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
- Conditions
- OHSS (Ovarian Hyperstimulation)
- Being tested
- Buserelin and Pregnyl, Pregnyl
- Keywords
- GnRH antagonist, GnRH agonist, hCG, OHSS, In vitro fertilization, ovulation induction, Clinical pregnancy rate
- 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.
Buserelin and PregnylDrug
Subcutaneous injection 0.5 mg and 1500 IU
PregnylDrug
Subcutaneous injection 5000 IU
Buserelin and PregnylDrug
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
PregnylDrug
Subcutaneous injection 5000 IU
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) Receives: Drug: Buserelin and Pregnyl |
| B | Active comparator | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) Receives: Drug: Pregnyl |
| C | Experimental | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) Receives: Drug: Buserelin and Pregnyl |
| D | Active comparator | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Receives: Drug: Pregnyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Moderate to Severe OHSS.
Measured: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
Secondary outcomes (1)
Pregnancy Rate
Measured: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OHSS (Ovarian Hyperstimulation)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
- Investigators
- Peter S Humaidan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627406
- Sponsor's protocol ID
- N-VN-2002-0046MCH
- Status last verified
- Sep 2013
- First submitted
- 22 Feb 2008
- Last updated
- 27 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Humaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9.
PubMed 23753114
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
- ClinicalTrials.gov ID
- NCT00627406
- Acronym / sponsor ID
- N-VN-2002-0046MCH
- Conditions
- OHSS (Ovarian Hyperstimulation)
- Keywords
- GnRH antagonist, GnRH agonist, hCG, OHSS, In vitro fertilization, ovulation induction, Clinical pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Posted 27 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Buserelin and PregnylMore than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) |
| B | Active comparator | Drug: PregnylMore than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) |
| C | Experimental | Drug: Buserelin and Pregnyl14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) |
| D | Active comparator | Drug: Pregnyl14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient complying with the conditions for IVF or ICSI treatment
- Female age over 20 years and under 40 years
- Normal regular cycle and patients with oligomenorrhea
- BMI > 18 and < 35
- each patient contributes with one cycle only
Key exclusion criteria (2 listed)
- Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
- Patients with > 25 follicles on the day of triggering ovulation
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 |
|---|---|---|
| Buserelin and PregnylSubcutaneous injection 0.5 mg and 1500 IU | Drug | A |
| PregnylSubcutaneous injection 5000 IU | Drug | B |
| Buserelin and PregnylSubcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days | Drug | C |
| PregnylSubcutaneous injection 5000 IU | Drug | D |
Primary outcome
Frequency of Moderate to Severe OHSS.
Time frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
1 secondary outcome
Pregnancy Rate
Time frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23753114Humaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9.
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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.
Peter S Humaidan, MD principal investigator
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 Buserelin and Pregnyl and Pregnyl in people with OHSS (Ovarian Hyperstimulation), run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 27 Nov 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Moderate to Severe OHSS. (time frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627406, which also lists 1 linked publication.
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 Nov 2013.