Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Claudio Benadiva, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00986687
First received: September 29, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

Vitrification is a method to cryopreserve biological specimens that are sensitive to chilling injury such as oocytes and embryos, and it has been employed with increased survival rate and live births (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000; Chung et al 2000; Wu et al., 2001: Kuwayama et al 2006). In their study the researchers propose to directly compare oocyte survival, fertilizaton and embryo development between sibling oocytes.

The Cryotop method of vitrification, which the researchers aim to investigate in their study, has been reported as the most efficient method for human oocytes cryopreservation (Kuwayama et al, 2005, Antinori et al, 2006, Lucena et al, 2006, Cobo et al, 2008). Follow up of over 200 infants conceived from vitrified oocytes (Chian et al, 2008) indicate that the mean birth weight and the incidence of congenital anomalies are comparable to that of spontaneous conceptions in fertile women or infertile women undergoing IVF treatment.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oocyte Cryopreservation: A Pilot Study Comparing Fertilization and Embryo Development Between Fresh and Vitrified Sibling Oocytes

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • oocyte survival [ Time Frame: day of retrieval ] [ Designated as safety issue: No ]
  • fertilization [ Time Frame: Day of retrieval ] [ Designated as safety issue: No ]
  • Embryo development [ Time Frame: day 3 post retrieval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation [ Time Frame: 3 weeks after transfer ] [ Designated as safety issue: No ]
  • Clinical pregnancy [ Time Frame: 2 weeks after transfer ] [ Designated as safety issue: No ]
  • Miscarriage and live birth rates for those embryos derived from vitrified oocytes. [ Time Frame: 9 months post transfer ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Embryos


Estimated Enrollment: 17
Study Start Date: August 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vitrified oocytes
Control oocytes

Detailed Description:

The necessity to cryopreserve human oocytes successfully, with the goal of achieving term pregnancies at rates equivalent to those obtained with fresh oocytes is urgent. Cryopreservation of oocytes is desirable because: 1) it would allow infertility patients to store excess oocytes instead of embryos, eliminating some of the ethical and religious concerns that accompany embryo storage; 2) permit storage of donor oocytes in egg banks, analogous to existing sperm banks. This option would allow the cryopreserved oocytes to be quarantined until screening for infectious diseases is completed, and would also avoid donor-recipient synchronization difficulties; and 3) can help cancer patients preserve their fertility before they face sterilization due to chemotherapy or radiation. Oocyte cryopreservation is therefore gaining in popularity as an option for infertility treatment as well as fertility preservation.

This is a pilot study to evaluate the outcomes of oocyte vitrification using the Cryotop method in women undergoing IVF, by simultaneously evaluating embryos derived from vitrified and fresh oocytes coming from the same stimulated cycle.

The primary outcome measures that will be tracked and tabulated are oocyte survival, fertilization and cleavage rate, and subsequent embryo development, compared between vitrified and fresh oocytes. Secondary outcomes are implantation, clinical pregnancy, miscarriage and live birth rates using embryos derived from the vitrified oocytes for transfer.

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Center for Advanced Reproductive Services patient population

Criteria

Inclusion Criteria:

  1. Females 21 to 37 years of age.
  2. Normal serum follicle stimulating hormone (FSH) concentration <10 mIU/ml and estradiol (E2) concentration <70 pg/ml obtained on day #2 or 3 of the menstrual cycle.
  3. BMI < 35.
  4. No physical or gynecological abnormalities (including major uterine surgery) constituting a medical contraindication to embryo transfer and pregnancy including any known significant genetic disorders
  5. Non-smoker for at least 3 months prior to study enrollment.
  6. Normal antral follicle count (total ≥ 10).

Exclusion Criteria:

  1. Greater than 1 previous miscarriage.
  2. More than 1 previous failed IVF attempt.
  3. Previous poor response to ovarian stimulation (peak E2 level <1,000 pg/ml or < 4 oocytes retrieved).
  4. Presence of untreated hydrosalpinx.
  5. Stage III or IV endometriosis.
  6. Intent to have preimplantation genetic diagnosis (PGD) of embryos
  7. Unwillingness to freeze or inseminate all eligible oocytes or embryos.
  8. Male partner requiring surgical sperm retrieval (MESA or TESA).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986687

Locations
United States, Connecticut
The Center for Advanced Reproductive Services
Farmington, Connecticut, United States, 06030-6224
Sponsors and Collaborators
University of Connecticut Health Center
EMD Serono
Investigators
Principal Investigator: Claudio Benadiva, MD, HCLD The Center for Advanced Reproductive Services, P.C.
  More Information

Additional Information:
Publications:

Responsible Party: Claudio Benadiva, Laboratory Director and Director of the Preimplantation Genetics Diagnosis Program,, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00986687     History of Changes
Other Study ID Numbers: 09-189-3, 29642
Study First Received: September 29, 2009
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Oocyte cryopreservation
vitrification

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

ClinicalTrials.gov processed this record on April 17, 2014