Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification
NCT ID: NCT00823121
Last Updated: 2010-01-20
Study Results
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Basic Information
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UNKNOWN
PHASE1/PHASE2
500 participants
INTERVENTIONAL
2008-08-31
2009-12-31
Brief Summary
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Detailed Description
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Oocyte retrieval was performed 34-36 hours after hCG administration and conventional insemination or ICSI was performed as clinically appropriate.
In 187 patients allocated to fresh ET group, ET were performed on the day 2. Embryos were transferred under ultrasound guidance, with a C.C.D. embryo transfer catheter (Laboratory C.C.D., Paris, France). Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM was started on the day of oocyte retrieval and continued until the documentation of fetal heart activity on ultrasound.
In 187 patients allocated to FET group, cryopreservation of all embryos were undertaken with vitrification by Cryotop method and after two months, embryos were transferred.
The protocol for the Cryotop vitrification of embryos was described previously (Kuwayama et al., 2005; Kuwayama, 2007).
After a two-step loading with equilibration solution containing 7.5% (v/v) ethylene glycol and 7.5% (v/v) dimethyl sulfoxide, and vitrification solution containing 15% (v/v) ethylene glycol, 15% (v/v) dimethyl sulfoxide and 0.5 mol/L sucrose, embryos were loaded with a narrow glass capillary onto the Cryotop in a volume of \< 0.1 µL . After loading, almost all the solution was removed to leave only a thin layer covering the embryos, and the sample was quickly immersed into liquid nitrogen (LN). Subsequently, the plastic cap was pulled over the film part of the Cryotop, and the sample was stored under LN. At warming, the protective cap was removed from the Cryotop while it was still submerged in LN and the Cryotop was immersed directly into a 37˚C medium containing sucrose. The embryos were then sequentially incubated in diluents solution before further in vitro culture for transfer.
Patients were prepared for ET with oral E2 to attain endometrial thickness ≥ 8 mm and triple line pattern on ultrasound scans. At that time, patients were given 100 mg of IM progesterone in oil daily and ET was preformed three days later under abdominal ultrasound guidance as described earlier. Oral E2 and progesterone were continued until documentation of fetal heart activity by ultrasonography.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
freezing embryos by vitrification
vitrification by Cryotop method
buserelin
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
recombinant FSH
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
human chorionic gonadotropin (pregnyl)
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
fresh embryo transfers
fresh embryo transfers
buserelin
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
recombinant FSH
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
human chorionic gonadotropin (pregnyl)
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
Interventions
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freezing embryos by vitrification
vitrification by Cryotop method
fresh embryo transfers
fresh embryo transfers
buserelin
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
recombinant FSH
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
human chorionic gonadotropin (pregnyl)
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* normal day 3 FSH
* classified as high risk for OHSS
* has ≥ 15 follicles with a mean diameter ≥ 12 mm per each ovary
* E2 levels on the day of hCG administration \> 3000 pg/mL
* undergoing her first assisted reproduction treatment cycle
Exclusion Criteria
18 Years
38 Years
FEMALE
Yes
Sponsors
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Yazd Research & Clinical Center for Infertility
OTHER
Responsible Party
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YazdRCCI
Principal Investigators
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abbas aflatoonian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research and Clinical Center for Infertility
homa oskouian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research and Clinical Center for Infertility
Locations
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: Research and clinical center for infertility
Yazd, Yazd Province, Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Aflatoonian A, Oskouian H, Ahmadi S, Oskouian L. Can fresh embryo transfers be replaced by cryopreserved-thawed embryo transfers in assisted reproductive cycles? A randomized controlled trial. J Assist Reprod Genet. 2010 Jul;27(7):357-63. doi: 10.1007/s10815-010-9412-9. Epub 2010 Apr 6.
Other Identifiers
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654YazdRCCI
Identifier Type: -
Identifier Source: org_study_id
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