Clinical trial NCT00713869: Oocyte Cryopreservation: Evaluation of an Oocyte Freezing and Thawing Technique
Official title: Evaluation of the Affects of an Oocyte Freezing and Thawing Technique in Patients Undergoing In-vitro Fertilization (IVF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Oocyte cryopreservation
Slow freeze
Lead sponsor: West Coast Fertility Centers
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertility patient

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Freeze / thaw survival rates. Fertilization rates. Cleavage rates. Embryo quality measured by pronuclear and day 2 morphology.
timeFrame: When oocyte thawed initiate.
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: West Coast Fertility Centers
state: California
Study officials:
affiliation: West Coast Fertility Centers
name: David G. Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References: