Infertility, FemaleNCT03020173
The Difference Seen in Granulosa Cells and Immature Oocytes in IVF Treated Patients Sorted by Body Mass Index (BMI)
An observational study of Infertility, Female, run by Hillel Yaffe Medical Center.
Trial summary
This study aims to discover the connection between BMI and oocyte and granulosa consistencies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Laboratory study
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women undergoing IVF treatment
Who may be able to join
- Infertile women undergoing IVF
- Consent to participate in study
Who cannot join
- Fertility preservation due to cancer
- Endocrine disorders
Trial locations and contacts
No sites are listed yet.
Rinat Lift, MSc contact
Shira Raviv, MD contact
About this study
This study aims to discover the connection between BMI and oocyte and granulosa consistencies.
- Conditions
- Infertility, Female
- Being tested
- Laboratory study
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory studyOther
Laboratory analysis to determine composition of granulosa and oocytes
| Study group | Role | What they receive |
|---|---|---|
| BMI above 30 | Oocytes and granulosa of infertile women with BMI above 30 Receives: Other: Laboratory study | |
| BMI below 30 | Oocytes and granulosa of infertile women with BMI above 30 Receives: Other: Laboratory study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of composition of granulosa cells and oocytes
Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels
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 posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020173
- Sponsor's protocol ID
- HYMC-0098-16
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Seen in Granulosa Cells and Immature Oocytes in IVF Treated Patients Sorted by Body Mass Index (BMI)
- ClinicalTrials.gov ID
- NCT03020173
- Acronym / sponsor ID
- HYMC-0098-16
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 Jan 2017 (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 study aims to discover the connection between BMI and oocyte and granulosa consistencies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI above 30 | – | Other: Laboratory studyOocytes and granulosa of infertile women with BMI above 30 |
| BMI below 30 | – | Other: Laboratory studyOocytes and granulosa of infertile women with BMI above 30 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing IVF treatment
Key inclusion criteria (2 listed)
- Infertile women undergoing IVF
- Consent to participate in study
Key exclusion criteria (2 listed)
- Fertility preservation due to cancer
- Endocrine disorders
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 |
|---|---|---|
| Laboratory studyLaboratory analysis to determine composition of granulosa and oocytes | Other | BMI above 30, BMI below 30 |
Primary outcome
Measurement of composition of granulosa cells and oocytes
Time frame: One year
Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Rinat Lift, MSc contact
Shira Raviv, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Hillel Yaffe Medical Center.
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 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: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Rinat Lift, MSc (rinatl@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of composition of granulosa cells and oocytes (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 13 Jan 2017.