Embryo transfers in assisted reproductive techniques are usually performed two days after the oocyte retrieval. Delaying transfer from day two to day three or four would allow for further development of the embryo, might therefore optimize the selection of viable and best quality embryos for transfer and may be closer to the physiological time of the entry into the uterus than transfer on day two, and might have a positive effect on pregnancy outcomes. The study aimed to determine whether delayed transfer of embryos from 2 to 3 or 4 days after oocyte retrieval and the pregnancy rate in ICSI (intra cytoplasmic sperm injection) procedure. All infertile couples accepting the controlled ovarian hyper stimulation (COH) plus intracytoplasmic sperm injection (ICSI) at fatemehzahra infertility center will be randomly at the two embryo transfers methods. (Embryo transfer in the second and third day or blastocyst stage). Serum pregnancy tests were performed 14 days after retrieval in all patients. When test results were positive, a second test will performed 2 days later. A viable pregnancy will defined as a pregnancy in which there will fetal cardiac activities on ultrasound at 6-7 weeks. Inclusion criteria included the men to aged 20-60 years and women to aged 20-40 years with any cause of infertility. Also at most of the embryos transfer are three numbers and all of embryos should be A, B grade. Other data analyzed included maternal age at the time of
Harvest, FSH levels within 1 year of harvest and on cycle days 2–4, number of oocytes, number of zygotes, and number of embryos transferred. After data collection, analysis carried out with test and chi squared tests. In an effort to establish the factors associated with the success of ICSI, multivariate analysis was performed based on logistic regression by using the statistical software Package, SPSS.16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205141760N18
Registration date:2012-08-15, 1391/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-15, 1391/05/25
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of pregnancy rate of day 2 versus day 3 and blastocyst embryo transfer in ICSI (intra cytoplasmic sperm injection) method
Public title
The comparison of pregnancy rate of day 2 versus day 3 and blastocyst embryo transfer in ICSI (intra cytoplasmic sperm injection) method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile couples with women aged 20-40 and men aged 20-60 with any cause of infertility؛ Patients with B-HCG test is positive 14 days after embryo transfer.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
580
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2011-11-30, 1390/09/09
Ethics committee reference number
5224/30/ژ/پ
Health conditions studied
1
Description of health condition studied
embryo transfer
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
Pregnancy
Timepoint
Five weeks after embryo transfer
Method of measurement
SONO - Vaginal
Secondary outcomes
1
Description
The number of embryos transferred
Timepoint
Five weeks after embryo transfer
Method of measurement
SONO - Vaginal
Intervention groups
1
Description
Intervention:
embryo transfer in the third day and blastocyst
Category
Treatment - Other
2
Description
Control:
Embryo transfer in the second day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Marmar Firoozpour Bandepey
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali bijani
Street address
Gangafroz Avenue, Vice Chancellor for Research and Technology, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Matab Zeinalzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zeinalmahtab@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Matab Zeinalzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
zeinalmahtab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani steert
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)