The aim of our study was to compare the resulting from transfer of embryos that cryopereserved in cleavage stage after thawing and transfer of embryos after thawing and culture in sequentional media until blastocyst formation. Methods and materials: In this prospective clinical study, we evaluate128 cycles in women undergone in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with embryo cryopreservation. Exclusion criteria were women with age >38 years and azospermia.Frozen embryos were thawed and then cultured in sequential media until blastocyst stage in blastocyst group and were compared with thawed embryos in cleavage stage group. The primary outcome is chemical pregnancy rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107306420N7
Registration date:2011-09-01, 1390/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2012-03-01, 1390/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos
Public title
Transfer of Blastocysts in cryopreseved cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women undergone in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with embryo cryopreservation.
Exclusion criteria: women with age >35 years; BMI>30; history of Diabetes Mellitus; thyroid disease; history of sever endometriosis.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Research and Clinical Center for Infertility, Yazd University of Medical Sciences
Street address
Safaeieh, Bouali Ave
City
Yazd
Postal code
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
927
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
12 days after embryo transfer
Method of measurement
blood laboartory kit
2
Description
clinical pregnancy
Timepoint
5 weeks after positive beta-hCG
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Miscarriage rate
Timepoint
lost of pregnancy before 20 gestational week
Method of measurement
absence of fetal heart activity in ultra sound sonography
Intervention groups
1
Description
Intervention: Thawing is done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culture is done for 3 days until blastocyst development. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Transfer of embryos is done 3 days after thawing and thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound .
Category
Treatment - Other
2
Description
Control: Thawing is done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transfered to uterine cavity 2 hours after thawing. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr.Abbas Aflatoonian
Street address
Bouali avenue , Safaieh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
YAazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
Other areas of specialty/work
Street address
Bouali avenue , Safaieh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
Other areas of specialty/work
Street address
Bouali avenue , Safaieh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Other areas of specialty/work
Street address
Bouali avenue ,safaieh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)