InfertilityNCT02520765
Obesity Index That Better Predict Ovarian Response
An observational study of Infertility, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Sep 2017
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: 200 patients who are admitted to the IVF center at Ain Shmas University hospital and scheduled for ICSI
Who may be able to join
- Patients scheduled for ICSI
Who cannot join
- Poor Responders.
- Poly cystic ovary syndrome.
- Previous ovarian surgeries.
- Patients with ovarian cysts
- patients with endometriosis
- women age more than 35 years
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate
ahmed kotb, MD, 2001008681999, ahmedmkotp@hotmail.com
ebtihal dr eltaieb, MD, 1004711414 ext. 0020, ahmedmkotp@hotmail.com
About this study
Official title: Obesity Index That Better Predict Ovarian Response: Body Mass Index, Waist Circumference, Waist Hip Ratio, or Waist Height Ratio in Women Undergoing ICSI
This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.
Read the detailed description
Obesity is an increasingly serious health concern worldwide, and its association with many diseases has been demonstrated. Obesity as it relates to infertility is also being studied All these studies used body mass index (BMI) to determine obesity. Although it is the most commonly used parameter to measure obesity, BMI does not provide an accurate measure of a person's body composition, including body fat.
Almost all studies conducted on this subject used body mass index (BMI) as the measure of obesity; however, using only BMI might be the wrong strategy. Interestingly, some studies on the cardiovascular system found protective effects of BMI and as a result a new term, 'obesity paradox,' emerged. Later studies used waist-to-hip (W/H) ratio and wrist circumference (WC) as a measure of obesity, and showed the exact effect of body fat distribution and obesity on the cardiovascular system
- Conditions
- Infertility
- Keywords
- Obesity Index, ICSI
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes
number f oocytes counted at the oocyte retrieval day during ICSI
Measured: 1 month
Secondary outcomes (1)
clinical pregnancy rate
detection of fetal cardiac activity by transvaginal ultrasound
Measured: 7 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Ahmed dr kotb, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520765
- Sponsor's protocol ID
- obesity index in ICSI
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2015
- Last updated
- 16 Aug 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 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Index That Better Predict Ovarian Response: Body Mass Index, Waist Circumference, Waist Hip Ratio, or Waist Height Ratio in Women Undergoing ICSI
- ClinicalTrials.gov ID
- NCT02520765
- Acronym / sponsor ID
- obesity index in ICSI
- Conditions
- Infertility
- Keywords
- Obesity Index, ICSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 13 Aug 2015 (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 is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.
Detailed description
Obesity is an increasingly serious health concern worldwide, and its association with many diseases has been demonstrated. Obesity as it relates to infertility is also being studied All these studies used body mass index (BMI) to determine obesity. Although it is the most commonly used parameter to measure obesity, BMI does not provide an accurate measure of a person's body composition, including body fat.
Almost all studies conducted on this subject used body mass index (BMI) as the measure of obesity; however, using only BMI might be the wrong strategy. Interestingly, some studies on the cardiovascular system found protective effects of BMI and as a result a new term, 'obesity paradox,' emerged. Later studies used waist-to-hip (W/H) ratio and wrist circumference (WC) as a measure of obesity, and showed the exact effect of body fat distribution and obesity on the cardiovascular system
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 200 patients who are admitted to the IVF center at Ain Shmas University hospital and scheduled for ICSI
Key inclusion criteria (1 listed)
- Patients scheduled for ICSI
Key exclusion criteria (6 listed)
- Poor Responders.
- Poly cystic ovary syndrome.
- Previous ovarian surgeries.
- Patients with ovarian cysts
- patients with endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of oocytes
Time frame: 1 month
number f oocytes counted at the oocyte retrieval day during ICSI
1 secondary outcome
clinical pregnancy rate
Time frame: 7 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Ahmed dr kotb, MD principal investigator
Ain Shams University
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, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 6 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 16 Aug 2017. 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 Egypt. 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 ahmed dr kotb, MD (1008681999 ext. 0020, ahmedmkotp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of oocytes (time frame: 1 month). 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 16 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.