Infertility Clinical Trial
Official title:
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
NCT number | NCT02793752 |
Other study ID # | MLFC-005 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | March 2017 |
Verified date | August 2020 |
Source | Main Line Fertility Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 42 Years |
Eligibility |
Inclusion Criteria: 1. Patients undergoing IVF in an attempt to achieve pregnancy. 2. Day 3 FSH < 10 IU/ml, LH< 12 IU/ml, and estradiol <50 pg/ml on day 2-4 of menstrual cycle 3. Antimullerian Hormone > 1.5 and < 10 4. Between 10 and 20 basal antral follicles on day 2-4 of the menstrual cycle 5. Body weight >50 kg, with BMI > 18 and < 32 kg/m2 Exclusion Criteria: 1. Smokers 2. Polycystic ovarian disease 3. Endometriosis greater than Stage I 4. Testicular or Epididymal Sperm 5. PGD/PGS |
Country | Name | City | State |
---|---|---|---|
United States | Main Line Fertility Center | Bryn Mawr | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Main Line Fertility Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mitochondrial respiration of cumulus Cells | Day of cumulus collection | ||
Primary | Blastocyst development | Five to six days after fertilization |
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