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
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 April 16, 2014