InfertilityNCT00631982
Invitro Maturation of Oocytes for Patients With Polycystic Ovaries
A study testing in vitro matuartion of oocytes in people with Infertility and Polycystic Ovaries, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with polycystic ovaries, to prevent cases of ovarian hyperstimulation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovaries
- What is being tested?
- in vitro matuartion of oocytes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Oct 2009
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovaries
- Needing IVF for fertility treatment
Who cannot join
- Age above 39
Trial locations and contacts
1 site in 1 country.
Raphael Ron - El, MD contact
Israel1 site
IVF and Infertility Unit, Assaf Harofeh Medical Center
Tsrifin, 70300
Raphael Ron-El, MD, +972-8-9779005
Raphael Ron - El, MD
About this study
Official title: In Vitro Maturation of Oocytes for Patients With Polycystic Ovaries
In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with polycystic ovaries, to prevent cases of ovarian hyperstimulation.
- Conditions
- Infertility, Polycystic Ovaries
- Being tested
- in vitro matuartion of oocytes
- Keywords
- in vitro maturation oocytes
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro matuartion of oocytesProcedure or surgery
in vitro maturation of (immature) oocytes
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | patients with PCO undergoing in vitro maturation and subsequently IVF and embryo transfer Receives: Procedure: in vitro matuartion of oocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
maturation rate,
Measured: 18 months
Secondary outcomes (1)
Fertilization rate, pregnancy rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631982
- Sponsor's protocol ID
- 22/08
- Status last verified
- Mar 2008
- First submitted
- 3 Mar 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation of Oocytes for Patients With Polycystic Ovaries
- ClinicalTrials.gov ID
- NCT00631982
- Acronym / sponsor ID
- 22/08
- Conditions
- Infertility, Polycystic Ovaries
- Keywords
- in vitro maturation oocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (estimated)
- First posted
- 10 Mar 2008 (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.
In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with polycystic ovaries, to prevent cases of ovarian hyperstimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: in vitro matuartion of oocytespatients with PCO undergoing in vitro maturation and subsequently IVF and embryo transfer |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Polycystic ovaries
- Needing IVF for fertility treatment
Key exclusion criteria (1 listed)
- Age above 39
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 matuartion of oocytesin vitro maturation of (immature) oocytes | Procedure or surgery | Group I |
Primary outcome
maturation rate,
Time frame: 18 months
1 secondary outcome
Fertilization rate, pregnancy rate
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Raphael Ron - El, MD contact
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 matuartion of oocytes in people with Infertility and Polycystic Ovaries, run by Assaf-Harofeh 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 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael Ron - El, MD (+972-8-9779005), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maturation rate, (time frame: 18 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 10 Mar 2008.