Polycystic Ovarian SyndromeNCT01237106
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
A study testing IVM in people with Polycystic Ovarian Syndrome, run by University Reproductive Associates at 2 sites in United States.
Trial summary
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- IVM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Nov 2012
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
- A diagnosis of PCOS by their primary MD
- An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion
- A day 3 FSH level of <8 IU/mL
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Male partner able to provide adequate semen sample by ejaculation (no TESE)
Who cannot join
- Current pregnancy
- Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
- Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
- have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Reproductive Associates
Hasbrouck Heights, New Jersey, 07604
University Reproductive Associates
Hoboken, New Jersey, 07030
About this study
Official title: In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.
In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- IVM
- Keywords
- PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVMOther
all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Maturation (IVM) | Experimental | Not described Receives: Other: IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Measured: 6 months
Secondary outcomes (4)
number of immature oocytes retrieved
Measured: 6 months
rates of maturation and fertilization
Measured: 6 months
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Measured: 6 months
live births
Measured: 1 1/2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Reproductive Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter McGovern, MD, University Reproductive Associates
- Investigators
- Peter G. McGovern, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237106
- Sponsor's protocol ID
- IRB 0120100297
- Status last verified
- Dec 2015
- First submitted
- 3 Nov 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
- ClinicalTrials.gov ID
- NCT01237106
- Acronym / sponsor ID
- IRB 0120100297
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Reproductive AssociatesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Nov 2010 (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.
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.
In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro Maturation (IVM) | Experimental | Other: IVM |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
- A diagnosis of PCOS by their primary MD
- An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion
- A day 3 FSH level of <8 IU/mL
- In good general health off of current medications which may confound response to study medications.
Key exclusion criteria (7 listed)
- Current pregnancy
- Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
- Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
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 |
|---|---|---|
| IVMall patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle. | Other | In Vitro Maturation (IVM) |
Primary outcome
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Time frame: 6 months
4 secondary outcomes
number of immature oocytes retrieved
Time frame: 6 months
rates of maturation and fertilization
Time frame: 6 months
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 6 months
live births
Time frame: 1 1/2 years
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 3 Dec 2015.
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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.
Peter G. McGovern, MD principal investigator
Rutgers, The State University of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVM in people with Polycystic Ovarian Syndrome, run by University Reproductive Associates at 2 sites in United States.
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 8 inclusion and 7 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does the primary outcome measure?
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level). (time frame: 6 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 3 Dec 2015.