Mitochondrial Activity of Cumulus Cells From the Cumulus-oocyte Complex and Oocyte Competence
A Prospective Study to Determine if Mitochondrial Activity of Cumulus Cells From the Cumulus-oocyte Complex is Associated With Maternal Age and Oocyte Competence to Blastocyst
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Background The number of couples undergoing in vitro fertilization (IVF) is rapidly growing worldwide. However, only approximately 5% of aspirated human oocytes have the competence to implant and develop into a child (Ziebe, 2013). Reasons for this low percentage of competence include genetic abnormalities and metabolic problems.
Moreover, this oocyte developmental competence decreases as a woman ages, and therefore maternal age is the single best predictor of reproductive outcome in women (Keefe et al, 2015). In general, the aging process is complex and includes impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and activity of several cell-signaling systems (Bentov, 2011).
Oocyte Competency is the Key to Embryo Potential The oocyte is the major determinant of embryo developmental competence in women. The oocyte transmits not only the mother's nuclear but also her mitochondrial genome to the embryo. The maternal and paternal genomes are neither symmetrical nor equal in their contributions to embryo fate.
Oxygen Consumption and Oocyte/Embryo Competence Clinically useful biomarkers of oocyte competency are needed (Keefe et al, 2015). Oxygen consumption is a quality marker for human oocyte competence conditioned by ovarian stimulation regimens (Tejera et al., 2011). Furthermore, oxygen consumption rates of embryos have been found to be associated with successful implantation and can be used to select the embryo with the best developmental potential (Tejera et al., 2012).
Rationale of Studying Cumulus Cells Ovarian follicles are highly specialized structures that support the growth and development of oocytes during controlled ovarian stimulation for IVF. Cumulus cells are somatic cells that form an intimate association with the oocyte in the follicle. Cumulus cells possess specialized cytoplasmic projections that penetrate through the zona pellucida [shell] and form gap junctions at their tips with the oocyte, generating an elaborate structure called the cumulus-oocyte complex (COC) (Albertini et al., 2001; Gilchrist et al., 2008). Cumulus cells metabolize the bulk of the glucose consumed by the COC to supply metabolic intermediates to the oocyte, and COC glucose metabolism is pivotal in determining oocyte developmental competence (Sutton-McDowall et al., 2010). It is well known that cumulus cells support oocyte development through the provision of essential nutrients, information molecules, metabolic precursors and signaling molecules (Hutt et al., 2007). Because of the metabolic and communication link between the cumulus and the oocyte, glucose availability and metabolism within the cumulus can have a significant impact on oocyte meiotic and developmental competence (Thompson JG, 2007).
If the coordinated somatic cell-oocyte interactions are perturbed by metabolic disease and/or maternal aging, molecular damage of the oocyte can alter macromolecules, induce mitochondrial mutations, all of which can harm the oocyte (Dumesic et al, 2015). For example, in 2015 Hsu et al. reported that endometriosis may be associated with mitochondrial dysfunction in pooled cumulus cells, and subjects with endometriosis may have a defect in cumulus cell mitochondrial function, which may contribute to decreased fertilization and implantation rates (Barnhart et al., 2002). The purpose of this study is to determine if the mitochondrial respiratory activity of cumulus cells is associated with maternal age and reproductive outcomes (oocyte competence).
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Main Line Fertility Center
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing IVF in an attempt to achieve pregnancy.
- Day 3 FSH < 10 IU/ml, LH< 12 IU/ml, and estradiol <50 pg/ml on day 2-4 of menstrual cycle
- Antimullerian Hormone > 1.5 and < 10
- Between 10 and 20 basal antral follicles on day 2-4 of the menstrual cycle
- Body weight >50 kg, with BMI > 18 and < 32 kg/m2
Exclusion Criteria:
- Smokers
- Polycystic ovarian disease
- Endometriosis greater than Stage I
- Testicular or Epididymal Sperm
- PGD/PGS
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Mitochondrial Activity of Cumulus Cells
One way that cumulus cells influence oocyte competence is via metabolism (Dumesic et al., 2015).
Analysis of mitochondria respiration is an established methodology used for evaluation of cell metabolic homeostasis and for diagnosis of different pathologies.
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Maternal Age
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Competence to Blastocyst
The percentage of fertilized eggs that develop to the blastocyst stage.
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Maternal Age
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mitochondrial respiration of cumulus Cells
Time Frame: Day of cumulus collection
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Day of cumulus collection
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Blastocyst development
Time Frame: Five to six days after fertilization
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Five to six days after fertilization
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Sharon H Anderson, PhD, Main Line Fertility Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MLFC-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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