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Sponsors and Collaborators: |
West Coast Fertility Centers EMD Serono |
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Information provided by: | West Coast Fertility Centers |
ClinicalTrials.gov Identifier: | NCT00713869 |
Over the past several decades, considerable effort has been expended toward the successful cryopreservation of various human cells. While attempts at cryopreservation have been directed at different tissue types, one of the most vigorously pursued targets has been reproductive tissue. Historically, cryopreservation of human sperm has existed for several decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker et al., 1984) from the cryopreservation of human embryos occurred in the early 1980s. Presently, the freezing and storage of human embryos following in vitro fertilization (IVF) is standard practice at most fertility clinics. In 2003, the CDC Assisted Reproductive Technology success rates report stated that 4,246 live births occurred out of 17,517 non-donor frozen embryo cycles. . Because the human egg is a relatively voluminous cell with abundant cytoplasm, crystallization at the time of freezing may result in damage to the organelles. Secondly, a mature metaphase II oocyte contains a fragile spindle apparatus involved in cleavage.
The purpose of this research study is to evaluate a method of freezing and thawing oocytes. This evaluation will be made by comparing the survival rates and rates of fertilization, cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same comparisons will be made between frozen oocytes from infertile women and those of egg donors. You are being asked to be in this study because you are currently undergoing in vitro fertilization.
Condition |
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Infertility |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Evaluation of the Affects of an Oocyte Freezing and Thawing Technique in Patients Undergoing in-Vitro Fertilization (IVF) |
Estimated Enrollment: | 50 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Patients between the ages of 21 and 35 undergoing in-vitro fertilization will be included in this study.
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Recipients using only frozen donor eggs
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Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Infertility patient
Inclusion Criteria:
To be eligible for inclusion into this study, each subject must satisfy the following criteria:
Exclusion Criteria:
A patient may NOT be entered into the study if she presents with ANY of the following criteria:
Contact: David G Diaz, MD | 714-513-1399 | tlsss@aol.com |
Contact: Antoine H La, BS | 714-513-1399 ext 118 | tlsss@aol.com |
United States, California | |
West Coast Fertility Centers | Recruiting |
Fountain Valley, California, United States, 92708 | |
Contact: David G Diaz, MD 714-513-1399 tlsss@aol.com | |
Contact: Antoine H La, BS 714-513-1399 ext 118 tlsss@aol.com | |
Principal Investigator: David G Diaz, MD |
Principal Investigator: | David G. Diaz, MD | West Coast Fertility Centers |
Responsible Party: | West Coast Fertility Centers ( David G. Diaz MD ) |
Study ID Numbers: | 20052092 |
Study First Received: | July 9, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00713869 |
Health Authority: | United States: Institutional Review Board |
Oocyte cryopreservation Slow freeze |
Genital Diseases, Female Infertility Genital Diseases, Male |