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
1 other identifier
observational
100
1 country
1
Brief Summary
The need for non-invasive biomarkers of oocyte competency has become urgent as women increasingly delay attempts at childbearing. The aging process is complex and includes impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and activity of several cell-signaling systems. Cumulus cells form an intimate association with the oocyte in the follicle, and they can have a significant impact on oocyte meiotic and developmental competence. In the IVF lab, the clump of cumulus cells is typically cut away from the oocyte immediately after an oocyte retrieval procedure, and then the cumulus cells are discarded. Measuring the mitochondrial respiratory activity of cumulus cells may serve as a non-invasive biomarker for oocyte competency and a predictor of reproductive success in IVF patients in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedAugust 11, 2020
August 1, 2020
11 months
June 3, 2016
August 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mitochondrial respiration of cumulus Cells
Day of cumulus collection
Blastocyst development
Five to six days after fertilization
Study Arms (2)
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.
Competence to Blastocyst
The percentage of fertilized eggs that develop to the blastocyst stage.
Interventions
Eligibility Criteria
Patients undergoing in vitro fertilization
You may qualify if:
- 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
You may not qualify if:
- Smokers
- Polycystic ovarian disease
- Endometriosis greater than Stage I
- Testicular or Epididymal Sperm
- PGD/PGS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010, United States
Related Links
Biospecimen
Cumulus Cells
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharon H Anderson, PhD
Main Line Fertility Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 8, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share