Objective: Determine predictive factors of embryo transfer on day 2 versus day 3 on intracytoplasmic sperm injection-embryo transfer cycles clinical outcomes.
Design: Single center randomized clinical trial.
Setting and conduct: Infertility & Reproductive Health Research Centre, Shahid Beheshti University of Medical Science, Thaleghani hospital.
Participants: All of the assisted reproductive technology cycles including agonist and antagonist from the date of 21.3.2013 to 21.12.2014, three hundred fresh intracytoplasmic sperm injection- embryo transfer cycles were included. Women aged 20-40 years and they have normal endometrial thickness (7-12 millimeters) on embryo transfers day and they have neither any visible endometrial pathology nor have more than three failed previous intracytoplasmic sperm injection-embryo transfer cycles.
Intervention: The embryo transfer in group I (control group) carried out on day3 and compared with embryo transfer on day2 (case group).
Main outcome measure(s): Predicting factors, Clinical pregnancy rate, Ongoing pregnancy rate, Chemical pregnancy, Miscarriage rate, Fertilization rate, Implantation rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121420306N1
Registration date:2015-01-02, 1393/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-02, 1393/10/12
Registrant information
Name
Shahrzad Zademodarres
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5530 1452
Email address
shahrzad.modarres@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine predictive factors of embryo transfer on day 2 versus day 3
on intracytoplasmic sperm injection-embryo transfer cycles clinical outcomes.
Public title
Effect of Embryo transfers day on infertility treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 20-40 years old undergoing fresh intracytoplasmic sperm injection-embryo transfer cycles; have normal endometrial thickness (7-12 milimeters) on embryo transfers day; don't have any visible endometrial pathology; do not have more than three failed previous intracytoplasmic sperm injection-embryo transfer cycles.
Exclusion criteria: abnormally shaped uterus in hysterosalpingography or hysteroscopy; have more than 3 previous failure of intracytoplasmic sperm injection-embryo transfer cycles .
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of
Street address
3rd floor, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
323
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N00-N99
ICD-10 code description
Noninflammatory disorders of female genital tract
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Five weeks after start of intervention
Method of measurement
Transvaginal ultrasonography
2
Description
Predicting factors
Timepoint
End of the treatment
Method of measurement
Statistical analysis
Secondary outcomes
1
Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Labratory kit
2
Description
Ongoing pregnancy rate
Timepoint
10weeks after embryo transfer
Method of measurement
History, physical exam, ultrasonography
3
Description
Miscariage rate
Timepoint
Until 24 weeks after start of intervention
Method of measurement
History, Physical exam, Ultrasonography
4
Description
Fertilization rate
Timepoint
After embryo development
Method of measurement
Labratory investigation
5
Description
implantation rate
Timepoint
Two weeks after embryo transfer
Method of measurement
History, Physical exam, Ultrasonography
Intervention groups
1
Description
Control group: The embryo transfer carried out on day3.
Category
Treatment - Other
2
Description
Intervention: Embryo transfer carried out on day2.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF ward, Mahdieh hospital
Full name of responsible person
Marzieh Zamanian
Street address
Mahdieh hospital, Shoosh square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Zahra Sadeghzade
Street address
IVF ward,Taleghani hospital, Velenjak , Shahid Chamran highway, Tehran
City
Tehran
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی شهیدبهشتی
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
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
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science
Full name of responsible person
Shahrzad Zademodarres
Position
Associate professor
Other areas of specialty/work
Street address
IVF ward,Taleghani Hospital, Velenjak, Shahid Chamran higway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
shahrzad.modarres2014@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Marzieh zamaniyan
Position
Obstetric and gynecologist
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
marziehzamaniyan@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Marzieh zamaniyan
Position
Obstetric and gynecologist
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
marziehzamaniyan@gmail.com
Web page address
irhrc.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)