Ovarian Hyperstimulation SyndromeNCT00835523
Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist
An observational study of Ovarian Hyperstimulation Syndrome, run by University Hospital Schleswig-Holstein at 10 sites in Germany.
Trial summary
The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- How many people
- 51 participants
- Where
- 10 sitesGermany
- Study dates
- May 2008to Jul 2010
- Phase
- Observational
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: IVF patients
Who may be able to join
- Indication for IVF with ICSI
- Age < 40 years
- < 4 failed previous IVF attempts with embryo transfer
- ovarian stimulation with GnRH-antagonist and gonadotrophins
- >20 follicles >11 mm in mean diameter or E2 >4500 pg/ml on the day , on which it was planned to administer hCG
- willing to participate and able to consent
- patient has not previously received GnRH-agonist as a trigger of final oocyte maturation
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
IVF-Augsburg
Augsburg, 86150
Deutsche Klinik Bad Münder
Bad Münder am Deister, 31848
Department of Obestrics and Gynecology, University Bonn
Bonn, 53127
Department of Obestrics and Gynecology, University Cologne
Cologne, 50931
Interdisziplinäres Kinderwunschzentrum
Düsseldorf, 40219
University Centre for Reproductive Medicine Franken
Erlangen, 91054
Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
Lübeck, 23538
Department of Obestrics and Gynecology, University Magdeburg
Magdeburg, 39108
Kinderwunschpraxis
Tübingen, 72070
Department of Obestrics and Gynecology, University Wuerzburg
Würzburg, 97080
About this study
Official title: OHSS Prevention by GnRH-agonist Triggering of Final Oocyte Maturation and Cryoperservation of All Two-pronucleate Oocytes in Women Undergoing Stimulation for IVF With Gonadotrophins and GnRH-analogues: a Prospective, Observational, Multicentric, Clinical Cohort Study
The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- frozen-thawed embryo replacement, GnRH agonist, GnRH antagonist, ovarian hyperstimulation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OHSS risk | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months
Measured: 12 months after recruitment
Secondary outcomes (7)
ongoing pregnancy rate/frozen-thawed ET
Measured: 12 months after recruitment
Ongoing pregnancy rate/first frozen-thawed ET
Measured: 12 months after recruitment
time to pregnancy in weeks
Measured: 12 months after recruitment
incidence of OHSS III°
Measured: 12 months after recruitment
number of cumulus-oocyte-complexes
Measured: 12 months after recruitment
fertilization rate (number COCs/number of 2 PN oocytes
Measured: 12 months after recruitment
survival rate (number of vital embryos/number of frozen 2 PN oocytes
Measured: 12 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Griesinger, University Hospital Schleswig-Holstein
- Investigators
- Georg Griesinger, PD Dr. med., Study chair, Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835523
- Sponsor's protocol ID
- OHSS 2009
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2009
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OHSS Prevention by GnRH-agonist Triggering of Final Oocyte Maturation and Cryoperservation of All Two-pronucleate Oocytes in Women Undergoing Stimulation for IVF With Gonadotrophins and GnRH-analogues: a Prospective, Observational, Multicentric, Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT00835523
- Acronym / sponsor ID
- OHSS 2009
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- frozen-thawed embryo replacement, GnRH agonist, GnRH antagonist, ovarian hyperstimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Feb 2009 (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 aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHSS risk | – | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- IVF patients
Key inclusion criteria (7 listed)
- Indication for IVF with ICSI
- Age < 40 years
- < 4 failed previous IVF attempts with embryo transfer
- ovarian stimulation with GnRH-antagonist and gonadotrophins
- >20 follicles >11 mm in mean diameter or E2 >4500 pg/ml on the day , on which it was planned to administer hCG
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months
Time frame: 12 months after recruitment
7 secondary outcomes
ongoing pregnancy rate/frozen-thawed ET
Time frame: 12 months after recruitment
Ongoing pregnancy rate/first frozen-thawed ET
Time frame: 12 months after recruitment
time to pregnancy in weeks
Time frame: 12 months after recruitment
incidence of OHSS III°
Time frame: 12 months after recruitment
number of cumulus-oocyte-complexes
Time frame: 12 months after recruitment
fertilization rate (number COCs/number of 2 PN oocytes
Time frame: 12 months after recruitment
survival rate (number of vital embryos/number of frozen 2 PN oocytes
Time frame: 12 months after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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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.
Georg Griesinger, PD Dr. med. study chair
Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Hyperstimulation Syndrome, run by University Hospital Schleswig-Holstein at 10 sites in Germany.
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 7 inclusion and 1 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months (time frame: 12 months after recruitment). 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 14 Jun 2012.