BMINCT01945671
The Influence of Obesity on Oocyte, Cumulus and Granulosa Functioning
An observational study of BMI and Lipid Profile, run by Hillel Yaffe Medical Center.
Trial summary
Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is a risk factor for anovulation , including in response to gonadotropin treatment .Further, even in women who are cycling regularly, obesity is associated with increased time-to-pregnancy and decreased chance of natural… Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- BMI, Lipid Profile
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2015
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients undergo IVF treatments
Who may be able to join
- All patients
Who cannot join
None listed.
About this study
Official title: The Influence of Obesity on Oocyte Functioning and Fertilization, Cumulus and Granulosa Functioning and Metabolic Factors.
Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is a risk factor for anovulation , including in response to gonadotropin treatment .Further, even in women who are cycling regularly, obesity is associated with increased time-to-pregnancy and decreased chance of natural pregnancy.
During obesity or periods of overnutrition, lipid accumulates in nonadipose tissues, notably skeletal muscle, liver, heart, and pancreas due to cellular uptake of exogenous fatty acids, triglycerides, and cholesterol as well as de novo lipogenesis in response to elevated glucose. The accumulation of intracellular lipid leads to high levels of free fatty acids that are subject to oxidative damage and the formation of cytotoxic and highly reactive lipid peroxides, which ultimately are detrimental to intracellular organelles, particularly the endoplasmic reticulum (ER) and mitochondria. Exposure of the ER to high levels of free fatty acids and lipid peroxides causes structural alterations that perturb ER function and lead to accumulation of unfolded proteins and calcium release. Failure of the UPR to reestablish ER homeostasis can lead to apoptosis .When mitochondria are exposed to high levels of free fatty acids, these can become oxidized by mitochondrial reactive oxygen species, forming lipid peroxides that damage essential proteins and uncouple mitochondrial function. This results in mitochondrial damage, which can cause further accumulation of lipids that cannot be catabolized, disrupted cellular homeostasis, and ultimately apoptosis .
Read more
The cellular mechanisms by which obesity causes decreased conception rates are not known. Based on extensive evidence of obesity-induced lipotoxicity in other cells, it was hypothesized that obesity results in the activation of lipotoxicity pathways in the ovary. It was shown that lipid accumulation, ER stress, mitochondrial dysfunction, and apoptosis occur in ovarian cells and the oocyte in response to a high-fat diet.
The aim of our study was to evaluate the influence of high BMI on oocytes, granulose cells and metabolites in the follicular fluid.
Read the detailed description
All women undergone IVF-ICSI cycles will be recruited in the study. They will be divided into 3 subgroups according to their BMI: 18.5-24.9 -normal; 25-29.9 - overweight ; ≥30 - obese.
- A blood sample will be collected on the day of OPU and several markers will be checked- triglycerides, free fatty acid, cholesterol (HDl, LDL), insulin, glucose, lactate, IGF-1, Leptin E2, Progessterone, IL-1, Il-6 and TNF-α. ii. After isolation of the oocytes from the follicular fluids - a blood free fluid from the leading follicle will be collected in a container for further evaluation of metabolic markers including triglycerides, free fatty acid, cholesterol (HDl, LDL), insulin, glucose, lactate, IGF-1, Leptin E2, Progessterone, IL-1, Il-6 and TNF-α , ROS. iii. Cumulus cells will be collected after denudation of oocytes for ICSI and will be analyzed for apoptosis marker - Caspase 3 staining , Tunnel iv. Oocytes diameter - all denudated oocytes will be captured in the inverted microscope and the diameter will be measured.
- GV oocytes, M1 and M2 that fail to fertilize will be analyzed for triglycerides, FFA and cholesterol concentration. vi. GDF-9, BMP-15, BMP-6, TNF-α, SMAD family will be analyzed by western blott as marker for oocytes quality. vii. Number of oocytes, mature (M2) oocytes, fertilization rate, cleavage rate, number embryos transferred, implantation rate, and pregnancy rate will be followed as well.
- Conditions
- BMI, Lipid Profile
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 1 year
Secondary outcomes (1)
lipid profile in different BMI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BMIStudies 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
- 80 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
- NCT01945671
- Sponsor's protocol ID
- HYMC 0070-13
- Status last verified
- Aug 2013
- First submitted
- 15 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Obesity on Oocyte Functioning and Fertilization, Cumulus and Granulosa Functioning and Metabolic Factors.
- ClinicalTrials.gov ID
- NCT01945671
- Acronym / sponsor ID
- HYMC 0070-13
- Conditions
- BMI, Lipid Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 18 Sep 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.
Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is a risk factor for anovulation , including in response to gonadotropin treatment .Further, even in women who are cycling regularly, obesity is associated with increased time-to-pregnancy and decreased chance of natural pregnancy.
During obesity or periods of overnutrition, lipid accumulates in nonadipose tissues, notably skeletal muscle, liver, heart, and pancreas due to cellular uptake of exogenous fatty acids, triglycerides, and cholesterol as well as de novo lipogenesis in response to elevated glucose. The accumulation of intracellular lipid leads to high levels of free fatty acids that are subject to oxidative damage and the formation of cytotoxic and highly reactive lipid peroxides, which ultimately are detrimental to intracellular organelles, particularly the endoplasmic reticulum (ER) and mitochondria. Exposure of the ER to high levels of free fatty acids and lipid peroxides causes structural alterations that perturb ER function and lead to accumulation of unfolded proteins and calcium release. Failure of the UPR to reestablish ER homeostasis can lead to apoptosis .When mitochondria are exposed to high levels of free fatty acids, these can become oxidized by mitochondrial reactive oxygen species, forming lipid peroxides that damage essential proteins and uncouple mitochondrial function. This results in mitochondrial damage, which can cause further accumulation of lipids that cannot be catabolized, disrupted cellular homeostasis, and ultimately apoptosis .
The cellular mechanisms by which obesity causes decreased conception rates are not known. Based on extensive evidence of obesity-induced lipotoxicity in other cells, it was hypothesized that obesity results in the activation of lipotoxicity pathways in the ovary. It was shown that lipid accumulation, ER stress, mitochondrial dysfunction, and apoptosis occur in ovarian cells and the oocyte in response to a high-fat diet.
The aim of our study was to evaluate the influence of high BMI on oocytes, granulose cells and metabolites in the follicular fluid.
Detailed description
All women undergone IVF-ICSI cycles will be recruited in the study. They will be divided into 3 subgroups according to their BMI: 18.5-24.9 -normal; 25-29.9 - overweight ; ≥30 - obese.
- A blood sample will be collected on the day of OPU and several markers will be checked- triglycerides, free fatty acid, cholesterol (HDl, LDL), insulin, glucose, lactate, IGF-1, Leptin E2, Progessterone, IL-1, Il-6 and TNF-α. ii. After isolation of the oocytes from the follicular fluids - a blood free fluid from the leading follicle will be collected in a container for further evaluation of metabolic markers including triglycerides, free fatty acid, cholesterol (HDl, LDL), insulin, glucose, lactate, IGF-1, Leptin E2, Progessterone, IL-1, Il-6 and TNF-α , ROS. iii. Cumulus cells will be collected after denudation of oocytes for ICSI and will be analyzed for apoptosis marker - Caspase 3 staining , Tunnel iv. Oocytes diameter - all denudated oocytes will be captured in the inverted microscope and the diameter will be measured.
- GV oocytes, M1 and M2 that fail to fertilize will be analyzed for triglycerides, FFA and cholesterol concentration. vi. GDF-9, BMP-15, BMP-6, TNF-α, SMAD family will be analyzed by western blott as marker for oocytes quality. vii. Number of oocytes, mature (M2) oocytes, fertilization rate, cleavage rate, number embryos transferred, implantation rate, and pregnancy rate will be followed as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients undergo IVF treatments
Key inclusion criteria (1 listed)
- All patients
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.
Primary outcome
pregnancy rate
Time frame: 1 year
1 secondary outcome
lipid profile in different BMI
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of BMI and Lipid Profile, 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 1 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 18 Sep 2013. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 1 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 18 Sep 2013.