Ovarian Hyperstimulation SyndromePhase 4NCT03188471
Preventive Application of GnRH Antagonist on Early OHSS
A Phase 4 study testing GnRH antagonist and aspirin in people with Ovarian Hyperstimulation Syndrome and GnRH Antagonist, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome, GnRH Antagonist, Aspirin
- What is being tested?
- GnRH antagonist and aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Mar 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- number of oocyte retrieval more than 25;
- estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration;
- clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.
Who cannot join
- contraindications to GnRH antagonist;
- coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
- GnRH agonist for trigger.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, Guangdong, 510080
eoshappy@163.com
Canquan Zhou
About this study
Official title: Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
Read the detailed description
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
- Conditions
- Ovarian Hyperstimulation Syndrome, GnRH Antagonist, Aspirin, Vascular Endothelial Growth Factor, Pigment Epithelium Derived Factor
- Being tested
- GnRH antagonist, aspirin
- 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.
GnRH antagonistDrug
Also called Vitamin C platelet
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
aspirinDrug
Also called saline as placebo of GnRH antagonist
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist | Experimental | Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days Receives: Drug: GnRH antagonist |
| aspirin | Active comparator | aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days. Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of early ovarian hyperstimulation syndrome
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification
Measured: up to 1 month
Secondary outcomes (8)
vascular endothelial growth factor level
VEGF level
Measured: up to 1 month
pigment epithelium derived factor level
PEDF level
Measured: up to 1 month
incidence of hydrothorax
one criterion for evaluation of OHSS severity
Measured: up to 1 month
incidence of liver dysfunction
one criterion for evaluation of OHSS severity
Measured: up to 1 month
incidence of renal dysfunction
one criterion for evaluation of OHSS severity
Measured: up to 1 month
incidence of electrolytic imbalance
one criterion for evaluation of OHSS severity
Measured: up to 1 month
incidence of hemoconcentration
one criterion for evaluation of OHSS severity
Measured: up to 1 month
incidence of elevated WBC
one criterion for evaluation of OHSS severity
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
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.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Qingyun Mai, Principal investigator, Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188471
- Sponsor's protocol ID
- antagonist
- Status last verified
- Jun 2017
- First submitted
- 10 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03188471
- Acronym / sponsor ID
- antagonist
- Conditions
- Ovarian Hyperstimulation Syndrome, GnRH Antagonist, Aspirin, Vascular Endothelial Growth Factor, Pigment Epithelium Derived Factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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 is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
Detailed description
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist | Experimental | Drug: GnRH antagonistVitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days |
| aspirin | Active comparator | Drug: aspirinaspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- number of oocyte retrieval more than 25;
- estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration;
- clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.
Key exclusion criteria (3 listed)
- contraindications to GnRH antagonist;
- coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
- GnRH agonist for trigger.
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 |
|---|---|---|
| GnRH antagonistAlso: Vitamin C plateletGnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients | Drug | GnRH antagonist |
| aspirinAlso: saline as placebo of GnRH antagonistaspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days | Drug | aspirin |
Primary outcome
Incidence and severity of early ovarian hyperstimulation syndrome
Time frame: up to 1 month
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification
8 secondary outcomes
vascular endothelial growth factor level
Time frame: up to 1 month
pigment epithelium derived factor level
Time frame: up to 1 month
incidence of hydrothorax
Time frame: up to 1 month
incidence of liver dysfunction
Time frame: up to 1 month
incidence of renal dysfunction
Time frame: up to 1 month
incidence of electrolytic imbalance
Time frame: up to 1 month
incidence of hemoconcentration
Time frame: up to 1 month
incidence of elevated WBC
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Ovarian Hyperstimulation Syndrome
RecruitingPhase 2
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)
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.
Qingyun Mai principal investigator
Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
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 GnRH antagonist and aspirin in people with Ovarian Hyperstimulation Syndrome and GnRH Antagonist, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 3 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 15 Jun 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Canquan Zhou (+86 20 87755766 ext. 8362, zhoucanquan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of early ovarian hyperstimulation syndrome (time frame: up to 1 month). 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 15 Jun 2017.