Oocyte Cryopreservation: The Impact of Cryopreservation on the Meiotic Spindle and Mitochondria of Human Oocytes. (WCFC)
This study has been completed.
Sponsor:
West Coast Fertility Centers
Information provided by:
West Coast Fertility Centers
ClinicalTrials.gov Identifier:
NCT00716118
First received: July 11, 2008
Last updated: January 5, 2011
Last verified: January 2011
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Purpose
Our aims is to document the possible effect of cryo- preservation at the meiotic spindle and mitochondrial levels.
| Condition |
|---|
|
Infertility |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Oocytes Cryopreservation: The Impact of Cryopreservation on the Meiotic Spindle and Mitochondria of Human Oocytes. |
Resource links provided by NLM:
Further study details as provided by West Coast Fertility Centers:
Primary Outcome Measures:
- To document the freeze/thaw survival rates of human oocytes and to compare the structure changes in their meiotic spindle and mitochondria before and after cryopreservation. [ Time Frame: When study complete ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
IVF patients.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 37 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Women of reproductive age who undergo controlled ovarian hyperstimulation (COH) for IVF are recruited for this study.
Criteria
Inclusion Criteria:
To be eligible for inclusion into this study, each subject must satisfy the following criteria:
- Participants must be aged 21 to 35 years
- Body mass index (BMI) < 38.
- Serum results for cycle day 3 FSH <10 mIU/ml.
- Be willing and able to comply with the protocol for the duration of the study.
- Have voluntarily provided written informed consent under WIRB, prior to any study-related procedure that is not part of normal medical care, with the understanding that the subjects may withdraw consent anytime without prejudice to their future medical care.
- Have passed a psychological and physical screening.
Exclusion Criteria:
A patient may NOT be entered into the study if she presents with ANY of the following criteria:
- Clinically significant systemic disease.
- Known endometriosis Grade III - IV (ASRM classification).
- Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of < 10 eggs at retrieval)
- Previous ovarian surgery
- Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
- Known current substance abuse.
- Simultaneous participation in another clinical trial.
- Current smoker.
- An extrauterine pregnancy within the last 3 months before OCP treatment commences.
- Previous participation in similar study at different centers.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716118
Locations
| United States, California | |
| West Coast Fertility Centers | |
| Fountain Valley, California, United States, 92708 | |
Sponsors and Collaborators
West Coast Fertility Centers
Investigators
| Principal Investigator: | David G Diaz, MD | West Coast Fertility Centers |
More Information
No publications provided
| Responsible Party: | David G. Diaz MD, West Coast Fertility Centers |
| ClinicalTrials.gov Identifier: | NCT00716118 History of Changes |
| Other Study ID Numbers: | 2008-02 |
| Study First Received: | July 11, 2008 |
| Last Updated: | January 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Coast Fertility Centers:
|
Oocyte Cryopreservation Slow-Freeze Egg Freezing |
Meiotic Spindle Mitochondria Human Oocytes Freezing. |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Miotics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013