ObeseNCT01473459
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients
A study testing IVM (In Vitro Maturation) Treatment and IVF (In Vitro Fertilization) Antagonist Protocol in people with Obese and Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese, Infertility, Polycystic Ovary Syndrome
- What is being tested?
- IVM (In Vitro Maturation) Treatment and IVF (In Vitro Fertilization) Antagonist Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Jan 2013
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 30
- PCOS
- Failure of COH treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.
Read the detailed description
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.
- Conditions
- Obese, Infertility, Polycystic Ovary Syndrome
- Being tested
- IVM (In Vitro Maturation) Treatment, IVF (In Vitro Fertilization) Antagonist Protocol
- Keywords
- best fertility protocol, (BMI > 30), women, PCOS
- Medical subject headings
- Obesity, Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVM (In Vitro Maturation) TreatmentProcedure or surgery
Also called IVM
There will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3.
IVF (In Vitro Fertilization) Antagonist ProtocolProcedure or surgery
Also called IVF - antagonist protocol
The first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3.
| Study group | Role | What they receive |
|---|---|---|
| IVM Treatment | Active comparator | Not described Receives: Procedure: IVM (In Vitro Maturation) Treatment |
| Antagonist Protocol | Active comparator | Not described Receives: Procedure: IVF (In Vitro Fertilization) Antagonist Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility results
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tal Shavit, M.D, Principal investigator, IVF unit Hillel-Yaffe medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473459
- Sponsor's protocol ID
- 0078-11-HYMC
- Status last verified
- Apr 2012
- First submitted
- 14 Nov 2011
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01473459
- Acronym / sponsor ID
- 0078-11-HYMC
- Conditions
- Obese, Infertility, Polycystic Ovary Syndrome
- Keywords
- best fertility protocol, (BMI > 30), women, PCOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 17 Nov 2011 (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 purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.
Detailed description
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVM Treatment | Active comparator | Procedure: IVM (In Vitro Maturation) Treatment |
| Antagonist Protocol | Active comparator | Procedure: IVF (In Vitro Fertilization) Antagonist Protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI > 30
- PCOS
- Failure of COH treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IVM (In Vitro Maturation) TreatmentAlso: IVMThere will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3. | Procedure or surgery | IVM Treatment |
| IVF (In Vitro Fertilization) Antagonist ProtocolAlso: IVF - antagonist protocolThe first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3. | Procedure or surgery | Antagonist Protocol |
Primary outcome
Fertility results
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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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.
Tal Shavit, M.D principal investigator
IVF unit Hillel-Yaffe 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 IVM (In Vitro Maturation) Treatment and IVF (In Vitro Fertilization) Antagonist Protocol in people with Obese and Infertility, run by Hillel Yaffe 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 3 inclusion and 0 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 26 Apr 2012. 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 Tal Shavit, MD (972-50-6246712, tal.shavit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility results (time frame: One year). 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 26 Apr 2012.