Polycystic Ovary SyndromeNCT00480337
In Vitro Maturation of Immature Oocytes
A study testing In Vitro Maturation of immature oocytes in people with Polycystic Ovary Syndrome and Ovarian Hyperstimulation Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
- What is being tested?
- In Vitro Maturation of immature oocytes
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with PCOS
- Women with previous Hyperstimulation or with risk of developing hyperstimulation during IVF Treatment
- Women diagnosed with cancer who are interested in fertility preservation
- Women with repeated IVF failure
Who cannot join
- Severe cases of endometriosis
- Large myomas
- Hydrosalpinxs Technical problem with previous oocytes pick-up
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure.
- Being tested
- In Vitro Maturation of immature oocytes
- Keywords
- PCOS, Fertility Preservation, Repeated IVF Failure, S/P Hyperstimulation
- Medical subject headings
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Maturation of immature oocytesProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ariel Hourvitz, Principal investigator, IVF Unit, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480337
- Sponsor's protocol ID
- SHEBA-06-4317-AH-CTIL
- Status last verified
- Dec 2008
- First submitted
- 29 May 2007
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation of Immature Oocytes
- ClinicalTrials.gov ID
- NCT00480337
- Acronym / sponsor ID
- SHEBA-06-4317-AH-CTIL
- Keywords
- PCOS, Fertility Preservation, Repeated IVF Failure, S/P Hyperstimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sheba Medical CenterOther government
- First posted
- 30 May 2007 (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 this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with PCOS
- Women with previous Hyperstimulation or with risk of developing hyperstimulation during IVF Treatment
- Women diagnosed with cancer who are interested in fertility preservation
- Women with repeated IVF failure
Key exclusion criteria (3 listed)
- Severe cases of endometriosis
- Large myomas
- Hydrosalpinxs Technical problem with previous oocytes pick-up
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 |
|---|---|---|
| In Vitro Maturation of immature oocytes | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 17 Dec 2008.
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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.
Ariel Hourvitz principal investigator
IVF Unit, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Vitro Maturation of immature oocytes in people with Polycystic Ovary Syndrome and Ovarian Hyperstimulation Syndrome, run by Sheba Medical Center at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 17 Dec 2008. 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 Israel. 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.
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 17 Dec 2008.