InfertilityNCT01672931
The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization
An observational study of Infertility and Obesity, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Obesity
- What is being tested?
- Oocyte Measurement
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2013
- 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: Women undergoing IVF treatments
Who may be able to join
- IVF treated patients
- BMI between 20-25 or over 30
Who cannot join
- Everyone else
Trial locations and contacts
1 site in 1 country.
About this study
We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30.
- Conditions
- Infertility, Obesity
- Being tested
- Oocyte Measurement
- Medical subject headings
- Infertility, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte MeasurementOther
| Study group | Role | What they receive |
|---|---|---|
| BMI over 30 | Women undergoing IVF with BMI over 30 Receives: Other: Oocyte Measurement | |
| BMI 20-25 | Women undergoing IVF treatments with BMI between 20-25 Receives: Other: Oocyte Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Larger Size of Oocyte Diameter
Oocyte will be measured in women undergoing IVF treatment
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 posted27 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gai Shrem, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672931
- Sponsor's protocol ID
- 0034-12 HYMC
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2012
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atzmon Y, Shoshan-Karchovsky E, Michaeli M, Aslih N, Shrem G, Ellenbogen A, Shalom-Paz E. Obesity results with smaller oocyte in in vitro fertilization/intracytoplasmic sperm injection cycles-a prospective study. J Assist Reprod Genet. 2017 Sep;34(9):1145-1151. doi: 10.1007/s10815-017-0975-6. Epub 2017 Jun 17.
PubMed 28624860
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01672931
- Acronym / sponsor ID
- 0034-12 HYMC
- Conditions
- Infertility, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 27 Aug 2012 (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.
We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI over 30 | – | Other: Oocyte MeasurementWomen undergoing IVF with BMI over 30 |
| BMI 20-25 | – | Other: Oocyte MeasurementWomen undergoing IVF treatments with BMI between 20-25 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF treatments
Key inclusion criteria (2 listed)
- IVF treated patients
- BMI between 20-25 or over 30
Key exclusion criteria (1 listed)
- Everyone else
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 |
|---|---|---|
| Oocyte Measurement | Other | BMI 20-25, BMI over 30 |
Primary outcome
Larger Size of Oocyte Diameter
Time frame: One year
Oocyte will be measured in women undergoing IVF treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Derived from this study: PubMed 28624860Atzmon Y, Shoshan-Karchovsky E, Michaeli M, Aslih N, Shrem G, Ellenbogen A, Shalom-Paz E. Obesity results with smaller oocyte in in vitro fertilization/intracytoplasmic sperm injection cycles-a prospective study. J Assist Reprod Genet. 2017 Sep;34(9):1145-1151. doi: 10.1007/s10815-017-0975-6. Epub 2017 Jun 17.
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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.
Gai Shrem, MD principal investigator
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?
An observational study of Infertility and Obesity, 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 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 27 Aug 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 Gai Shrem, MD (972-50-6793080, gai.shrem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Larger Size of Oocyte Diameter (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672931, which also lists 1 linked publication.
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 27 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.