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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716118
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : January 6, 2011
Information provided by:
West Coast Fertility Centers

Brief Summary:
Our aims is to document the possible effect of cryo- preservation at the meiotic spindle and mitochondrial levels.

Condition or disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oocytes Cryopreservation: The Impact of Cryopreservation on the Meiotic Spindle and Mitochondria of Human Oocytes.
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

IVF patients.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716118

United States, California
West Coast Fertility Centers
Fountain Valley, California, United States, 92708
Sponsors and Collaborators
West Coast Fertility Centers
Principal Investigator: David G Diaz, MD West Coast Fertility Centers

Responsible Party: David G. Diaz MD, West Coast Fertility Centers Identifier: NCT00716118     History of Changes
Other Study ID Numbers: 2008-02
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by West Coast Fertility Centers:
Oocyte Cryopreservation
Egg Freezing
Meiotic Spindle
Human Oocytes Freezing.

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female