Ovarian Hyperstimulation SyndromePhase 4NCT00349258
The Use of GnRH Agonist Trigger in the Prevention of OHSS
A Phase 4 study testing Leuprolide acetate in people with Ovarian Hyperstimulation Syndrome, run by University of Connecticut at 1 site in United States.
Trial summary
To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Leuprolide acetate
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 2006
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-39
- normal early follicular phase serum FSH (≤10.0 IU/l)
- patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.
Who cannot join
- Hypogonadotropic hypogonadism
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Advanced Reproductive Services, UCHC
Farmington, Connecticut, 06032
About this study
Official title: A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment
To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.
Read the detailed description
OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.
hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.
There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.
High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Leuprolide acetate
- Keywords
- OHSS, PCOS, Previous high response, GnRH antagonist, GnRH agonist, IVF
- 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.
Leuprolide acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
OHSS occurrence assessed one week after oocyte retrieval
Implantation rate assessed at seven weeks gestation
Secondary outcomes (3)
Clinical Pregnancy rate assessed at time of ultrasound
Mature oocytes assessed at time of retrieval
Ovarian volume assessed one week after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startAug 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Investigators
- Claudio Benadiva, MD, Principal investigator, UConn HealthLawrence Engmann, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349258
- Sponsor's protocol ID
- 04-277
- Status last verified
- Feb 2006
- First submitted
- 5 Jul 2006
- Last updated
- 6 Jul 2006
- Results posted
- No
Publications
Engmann L, Romak J, Nulsen J, Benadiva C, Peluso J. In vitro viability and secretory capacity of human luteinized granulosa cells after gonadotropin-releasing hormone agonist trigger of oocyte maturation. Fertil Steril. 2011 Jul;96(1):198-202. doi: 10.1016/j.fertnstert.2011.04.071. Epub 2011 May 20.
PubMed 21601197
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT00349258
- Acronym / sponsor ID
- 04-277
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OHSS, PCOS, Previous high response, GnRH antagonist, GnRH agonist, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Aug 2004
- Study completion
- May 2006
- First posted
- 6 Jul 2006 (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 compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.
Detailed description
OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.
hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.
There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.
High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 20-39
- normal early follicular phase serum FSH (≤10.0 IU/l)
- patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.
Key exclusion criteria (1 listed)
- Hypogonadotropic hypogonadism
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 |
|---|---|---|
| Leuprolide acetate | Drug | – |
Primary outcome
OHSS occurrence assessed one week after oocyte retrieval
Implantation rate assessed at seven weeks gestation
3 secondary outcomes
Clinical Pregnancy rate assessed at time of ultrasound
Mature oocytes assessed at time of retrieval
Ovarian volume assessed one week after oocyte retrieval
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 6 Jul 2006.
- Derived from this study: PubMed 21601197Engmann L, Romak J, Nulsen J, Benadiva C, Peluso J. In vitro viability and secretory capacity of human luteinized granulosa cells after gonadotropin-releasing hormone agonist trigger of oocyte maturation. Fertil Steril. 2011 Jul;96(1):198-202. doi: 10.1016/j.fertnstert.2011.04.071. Epub 2011 May 20.
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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.
Claudio Benadiva, MD principal investigator
UConn Health
Lawrence Engmann, MD principal investigator
UConn Health
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 Leuprolide acetate in people with Ovarian Hyperstimulation Syndrome, run by University of Connecticut at 1 site in United States.
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 3 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 6 Jul 2006. 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 United States. 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 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?
OHSS occurrence assessed one week after oocyte retrieval. The study lists 2 primary outcomes in all. 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 NCT00349258, 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 6 Jul 2006.