Oocyte Cryopreservation: The Impact of Cryopreservation on the Meiotic Spindle and Mitochondria of Human Oocytes. (WCFC)

This study has been completed.
Sponsor:
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
  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:

  1. Participants must be aged 21 to 35 years
  2. Body mass index (BMI) < 38.
  3. Serum results for cycle day 3 FSH <10 mIU/ml.
  4. Be willing and able to comply with the protocol for the duration of the study.
  5. 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.
  6. 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:

  1. Clinically significant systemic disease.
  2. Known endometriosis Grade III - IV (ASRM classification).
  3. Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of < 10 eggs at retrieval)
  4. Previous ovarian surgery
  5. Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
  6. Known current substance abuse.
  7. Simultaneous participation in another clinical trial.
  8. Current smoker.
  9. An extrauterine pregnancy within the last 3 months before OCP treatment commences.
  10. Previous participation in similar study at different centers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014