Skip to content

Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes

Oocyte Cryopreservation: A Pilot Study Comparing Fertilization and Embryo Development Between Fresh and Vitrified Sibling Oocytes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00986687
Enrollment
17
Registered
2009-09-30
Start date
2009-08-31
Completion date
2013-02-28
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Oocyte cryopreservation, vitrification

Brief summary

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.

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.

Interventions

None listed

Sponsors

EMD Serono
CollaboratorINDUSTRY
UConn Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 37 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
oocyte survivalday of retrieval
fertilizationDay of retrieval
Embryo developmentday 3 post retrieval

Secondary

MeasureTime frame
Implantation3 weeks after transfer
Clinical pregnancy2 weeks after transfer
Miscarriage and live birth rates for those embryos derived from vitrified oocytes.9 months post transfer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026