Weight LossNCT01844128
The Effect of Weight Loss on Ovarian Reserve
An observational study of Weight Loss, run by Meir Medical Center at 1 site in Israel.
Trial summary
Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Weight Loss
- What is being tested?
- weight loss
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Apr 2014
- How long will I take part?
- 1 Year
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Overweight women with infertility
Who may be able to join
- undergoing weight loss program
Who cannot join
- dropp out before comletion the weighy loss target
Trial locations and contacts
1 site in 1 country.
Amir Wiswe, MD contact
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Overweight &Infertility clinic, 097471555
Amir Wiser, MD
About this study
Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed.
The first line treatment for those women with obesity and infertility is weight loss.
The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility treatment outcome.
Read the detailed description
The investigators have outpatient clinic for obesity and infertility. the patients undergoing program of 3 months with diet and physical activity. Blood sample will take at the beginning of the program and at the end. The blood sample will evaluate for: AMH, Adiponectin, Leptin, CRP, Colesterol, CRP, Smac in addition TVUS will perform to evaluate AFC.
- Conditions
- Weight Loss
- Being tested
- weight loss
- Keywords
- MMA, AFC, Ovarian reserve
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight lossDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| overweight women with infertility | Not described Receives: Dietary Supplement: weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Mullerain Hormone (AMH)and AFC before and after weight loss
AMH and AFC will measure at the first visit and after 3 months of weight loss program
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Wiser, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844128
- Sponsor's protocol ID
- 0257-12mmc
- Status last verified
- Apr 2013
- First submitted
- 28 Apr 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight Loss on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01844128
- Acronym / sponsor ID
- 0257-12mmc
- Conditions
- Weight Loss
- Keywords
- MMA, AFC, Ovarian reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 1 May 2013 (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.
Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed.
The first line treatment for those women with obesity and infertility is weight loss.
The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility treatment outcome.
Detailed description
The investigators have outpatient clinic for obesity and infertility. the patients undergoing program of 3 months with diet and physical activity. Blood sample will take at the beginning of the program and at the end. The blood sample will evaluate for: AMH, Adiponectin, Leptin, CRP, Colesterol, CRP, Smac in addition TVUS will perform to evaluate AFC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| overweight women with infertility | – | Dietary Supplement: weight loss |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overweight women with infertility
Key inclusion criteria (1 listed)
- undergoing weight loss program
Key exclusion criteria (1 listed)
- dropp out before comletion the weighy loss target
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 |
|---|---|---|
| weight loss | Dietary supplement | overweight women with infertility |
Primary outcome
Anti Mullerain Hormone (AMH)and AFC before and after weight loss
Time frame: 3 months
AMH and AFC will measure at the first visit and after 3 months of weight loss program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
Amir Wiswe, MD contact
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 Weight Loss, run by Meir 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 1 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 11 Jun 2013. 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 Amir Wiswe, MD (+97297472227), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Mullerain Hormone (AMH)and AFC before and after weight loss (time frame: 3 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 11 Jun 2013.