Ovarian Hyperstimulation SyndromePhase 4NCT02670304
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
A Phase 4 study testing letrozole and Aspirin in people with Ovarian Hyperstimulation Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- letrozole and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2013
- 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
- infertile women undergoing IVF treatment with more than 25 oocytes collected.
Who cannot join
- letrozole contraindications,e.g. severe hepatic and renal dysfunction
About this study
Official title: The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.
Read the detailed description
Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- letrozole, ovarian hyperstimulating syndrome
- 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.
letrozoleDrug
Also called Femara
letrozole from the day of oocyte retrieval for 5 days
AspirinDrug
aspirin from the day of oocyte retrieval for 5 days
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Experimental | letrozole for the first day after ovum picked up at least for 5 days. Receives: Drug: letrozole |
| aspirin | Active comparator | asprin for the first day after ovum picked up at least for 5 days. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of early OHSS
Measured: up to 1 months
Secondary outcomes (7)
vascular endothelial growth factor level
vascular endothelial growth factor in pg/ml
Measured: up to 1 months
incidence of hydrothorax
Measured: up to 1 months
incidence of liver dysfunction
Measured: up to 1 months
incidence of renal dysfunction
Measured: up to 1 months
incidence of electrolytic imbalance
Measured: up to 1 months
incidence of hemoconcentration
Measured: up to 1 months
incidence of elevated WBC
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionAug 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670304
- Sponsor's protocol ID
- 28843020
- Status last verified
- Jan 2016
- First submitted
- 7 Aug 2013
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT02670304
- Acronym / sponsor ID
- 28843020
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- letrozole, ovarian hyperstimulating syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Feb 2016 (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.
Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.
Detailed description
Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole | Experimental | Drug: letrozoleletrozole for the first day after ovum picked up at least for 5 days. |
| aspirin | Active comparator | Drug: Aspirinasprin for the first day after ovum picked up at least for 5 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women undergoing IVF treatment with more than 25 oocytes collected.
Key exclusion criteria (1 listed)
- letrozole contraindications,e.g. severe hepatic and renal dysfunction
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 |
|---|---|---|
| letrozoleAlso: Femaraletrozole from the day of oocyte retrieval for 5 days | Drug | letrozole |
| Aspirinaspirin from the day of oocyte retrieval for 5 days | Drug | aspirin |
Primary outcome
incidence of early OHSS
Time frame: up to 1 months
7 secondary outcomes
vascular endothelial growth factor level
Time frame: up to 1 months
incidence of hydrothorax
Time frame: up to 1 months
incidence of liver dysfunction
Time frame: up to 1 months
incidence of renal dysfunction
Time frame: up to 1 months
incidence of electrolytic imbalance
Time frame: up to 1 months
incidence of hemoconcentration
Time frame: up to 1 months
incidence of elevated WBC
Time frame: up to 1 months
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 1 Feb 2016.
- Individual participant dataSharing planned: No. no plan to make IPD available
Related trials for Ovarian Hyperstimulation Syndrome
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing letrozole and Aspirin in people with Ovarian Hyperstimulation Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University.
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 1 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of early OHSS (time frame: up to 1 months). 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 1 Feb 2016.