InfertilityNCT02635425
Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome
A study testing 7 eggs collection and Full eggs collection in people with Infertility, run by Ahmad Hussieny Salama at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- 7 eggs collection and Full eggs collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Mar 2016
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- More than 9 days of induction of ovulation.
- Each ovary contains more than 20 follicles.
- The majority of follicles are >14mm in diameter.
- Mild fluid in Douglas pouch.
- The patient started to complain of considerable lower abdominal pains before the egg collection.
Who cannot join
- Recurrent ICSI failure or bad obstetric history.
- Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases
The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.
Read the detailed description
Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients.
Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.
- Conditions
- Infertility
- Being tested
- 7 eggs collection, Full eggs collection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 eggs collectionProcedure or surgery
vaginal US
Full eggs collectionProcedure or surgery
vaginal US
| Study group | Role | What they receive |
|---|---|---|
| 7 eggs collection | Experimental | Aspiration of 7 eggs only Receives: Procedure: 7 eggs collection |
| Full eggs collection | Active comparator | Aspiration of all eggs Receives: Procedure: Full eggs collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
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.
- Other trials for InfertilityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Hussieny Salama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Hussieny Salama, Ain Shams Maternity Hospital
- Investigators
- Ahmed H Salama, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635425
- Sponsor's protocol ID
- LFOHSS
- Status last verified
- Apr 2016
- First submitted
- 12 Dec 2015
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases
- ClinicalTrials.gov ID
- NCT02635425
- Acronym / sponsor ID
- LFOHSS
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmad Hussieny SalamaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Posted 19 Apr 2016
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 evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.
Detailed description
Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients.
Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 eggs collection | Experimental | Procedure: 7 eggs collectionAspiration of 7 eggs only |
| Full eggs collection | Active comparator | Procedure: Full eggs collectionAspiration of all eggs |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- More than 9 days of induction of ovulation.
- Each ovary contains more than 20 follicles.
- The majority of follicles are >14mm in diameter.
- Mild fluid in Douglas pouch.
- The patient started to complain of considerable lower abdominal pains before the egg collection.
Key exclusion criteria (2 listed)
- Recurrent ICSI failure or bad obstetric history.
- Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.
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 |
|---|---|---|
| 7 eggs collectionvaginal US | Procedure or surgery | 7 eggs collection |
| Full eggs collectionvaginal US | Procedure or surgery | Full eggs collection |
Primary outcome
Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmed H Salama, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 eggs collection and Full eggs collection in people with Infertility, run by Ahmad Hussieny Salama at 1 site in Egypt.
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 19 May 2016. 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 Egypt. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2016). 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?
Number of Participants of Severe Ovarian Hyperstimulation Syndrome (time frame: 2 weeks). 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 19 May 2016.