Oocyte Cryopreservation: Evaluation of an Oocyte Freezing and Thawing Technique (Slow-freeze)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by West Coast Fertility Centers.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
West Coast Fertility Centers
ClinicalTrials.gov Identifier:
NCT00713869
First received: July 9, 2008
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the Affects of an Oocyte Freezing and Thawing Technique in Patients Undergoing In-vitro Fertilization (IVF)

Resource links provided by NLM:


Further study details as provided by West Coast Fertility Centers:

Primary Outcome Measures:
  • Freeze / thaw survival rates. Fertilization rates. Cleavage rates. Embryo quality measured by pronuclear and day 2 morphology. [ Time Frame: When oocyte thawed initiate. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2006
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients between the ages of 21 and 35 undergoing in-vitro fertilization will be included in this study.
2
Recipients using only frozen donor eggs

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infertility patient

Criteria

Inclusion Criteria:

To be eligible for inclusion into this study, each subject must satisfy the following criteria:

  1. Infertile woman wishing to conceive and whose physician has recommended that she undergo IVF.
  2. Participants must be aged 21 to 35 years
  3. Body mass index (BMI) < 38.
  4. Serum results for cycle day 3 FSH <10 mIU/ml.
  5. Must have male partner whose semen analysis meets the clinic criteria for ICSI. Use of donor sperm is also acceptable.
  6. Be willing and able to comply with the protocol for the duration of the study.
  7. 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 before they start Lupron without prejudice to their future medical care.

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. Three or more previous ART cycles without a clinical pregnancy
  5. Abnormal, undiagnosed, gynecological bleeding.
  6. Previous ovarian surgery
  7. Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
  8. Known current substance abuse.
  9. Simultaneous participation in another clinical trial.
  10. Current smoker.
  11. An extrauterine pregnancy within the last 3 months before OCP treatment commences.
  12. 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: NCT00713869

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

Additional Information:
No publications provided

Responsible Party: David G. Diaz MD, West Coast Fertility Centers
ClinicalTrials.gov Identifier: NCT00713869     History of Changes
Other Study ID Numbers: 20052092
Study First Received: July 9, 2008
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by West Coast Fertility Centers:
Oocyte cryopreservation
Slow freeze

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

ClinicalTrials.gov processed this record on July 26, 2014