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

NCT00716118 | Completed DMC

• 1 other identifier: 2008-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

Oocyte Cryopreservation; Slow-Freeze; Egg Freezing; Meiotic Spindle; Mitochondria; Human Oocytes Freezing.

Outcome Measures

Primary Outcomes (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.

  When study complete

Study Arms (1)

1

IVF patients.

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of reproductive age who undergo controlled ovarian hyperstimulation (COH) for IVF are recruited for this study.

You may qualify if:

• Participants must be aged 21 to 35 years
• Body mass index (BMI) \< 38.
• Serum results for cycle day 3 FSH \<10 mIU/ml.
• Be willing and able to comply with the protocol for the duration of the study.
• 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.
• Have passed a psychological and physical screening.

You may not qualify if:

• A patient may NOT be entered into the study if she presents with ANY of the following criteria:
• Clinically significant systemic disease.
• Known endometriosis Grade III - IV (ASRM classification).
• Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of \< 10 eggs at retrieval)
• Previous ovarian surgery
• Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
• Known current substance abuse.
• Simultaneous participation in another clinical trial.
• Current smoker.
• An extrauterine pregnancy within the last 3 months before OCP treatment commences.
• Previous participation in similar study at different centers.

Sponsors & Collaborators

• West Coast Fertility Centers: lead

Study Sites (1)

West Coast Fertility Centers

Fountain Valley, California, 92708, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• David G Diaz, MD

  West Coast Fertility Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 6, 2011

Record last verified: 2011-01

Locations

US (1)