Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes
| Status: | Completed |
|---|---|
| Conditions: | Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 37 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | February 2013 |
Oocyte Cryopreservation: A Pilot Study Comparing Fertilization and Embryo Development Between Fresh and Vitrified Sibling Oocytes
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.
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.
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.
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.
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).
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