The aim of this study is evaluating the role of cosmetic micromanipulation on vitrified-warmed human cleavage stage embryos on assisted reproductive technology outcome. 96 Patients that are undergoing frozen embryo transfer (FET) with similar clinical characteristics are included in this prospective randomized study. They are divided into three groups of cosmetic micromanipulation (CM; n=32), laser assisted zona hatching (LAH; n=32) and control(n=32). CM is defined as removal of fragments and coarse granules from the vitrified- warmed embryos before embryo transfer (ET). The days 2 or 3 vitrified-warmed embryos with grades of B or C are included in this study. The patients with multinucleated or revitrified-warmed embryos are excluded from study.In CM group, a few hours after embryo warming and morphology evaluation, the embryo are subjected to CM after LAH .Whereas; in LAH group warmed embryos are subjected to LAH only. After overnight incubation, cell division and morphology of embryos are evaluated and divided embryos are transferred. the ART outcome are followed up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030421332N1
Registration date:2015-06-01, 1394/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Somayyeh Safari
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd,
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7088
Email address
ssafari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd and Research and Clinical Center for Infertility,Yazd
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Role of Cosmetic Micromanipulation on Vitrified-Warmed Human Cleavage stage Embryos on Assisted Reproductive Technology Outcome
Public title
Evaluating the Role of Cosmetic Micromanipulation on Vitrified-Warmed Human Cleavage stage Embryos on Assisted Reproductive Technology Outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing IVF/ICSI who have fragmented vitrified-warmed days 2 or 3 embryos with morphology grades of B and C.
Exclusion criteria: Patients with multi-nucleated or revitrified-warmed embryos
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Postal code
8916877391
Approval date
2013-06-20, 1392/03/30
Ethics committee reference number
174
Health conditions studied
1
Description of health condition studied
infertile patients
ICD-10 code
N97
ICD-10 code description
Female infertility
2
Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after transfer of embryos into uterine
Method of measurement
measuring bhCG level in blood
2
Description
Clinical pregnancy
Timepoint
heart beat in 7th week of gestation
Method of measurement
observation of heart beat with ultrasound
Secondary outcomes
1
Description
Cell division in embryo
Timepoint
overnight after vitrified embryo warming
Method of measurement
by inverted microscope
Intervention groups
1
Description
Intervention: assisted laser hatching and microsurgery on embryo for removal the fragments or granules surrounded the blastomeres
Category
Other
2
Description
control: without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Somayyeh Safari
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr.Ali Mohammad Abdoli
Street address
Bouali Ave, Safaeiyeh
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Somayyeh Safari
Position
Ph.D candidate in reproductive medicine
Other areas of specialty/work
Street address
Bouali Ave, Safaeiyeh
City
yazd
Postal code
Phone
+98 35 3824 7088
Fax
Email
safari.so2006@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Khalili
Position
PhD of anatomy
Other areas of specialty/work
Street address
Bouali Ave, Safaeiyeh
City
yazd
Postal code
Phone
+98 35 3824 7088
Fax
Email
khalili59@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Somayyeh Safari
Position
Ph.D candidate in reproductive biology
Other areas of specialty/work
Street address
Bouali Ave, Safaeiyeh
City
YAZD
Postal code
Phone
+98 35 3824 7088
Fax
Email
safari.so2006@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)