Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. .
Oocytes incubated in IVF medium at 37 °C with 7.3%CO2 and 5 % O2 in air with saturated humidity. Then surrounding cumulus oophorus and corona radiata cells removed for intracytoplasmic sperm injection (ICSI). Finally Oocytes were fertilized by either insemination (IVF) or ICSI. embryos
were cultured in sequential media .
The women will be randomly divided into two groups A fresh transfer was performed either on Day 3 or on day 5 after.The luteal phase was supported by vaginal progesterone 600 mg daily.
Participants/Inclusion and exclusion criteria
Inclusion criteria:uterine with normal cavity; Normal respond er to ovarian stimulation;there are at least 5 fresh embryos and sufficient thickness of endometrium in day 12 cycles
Exclusion criteria: lack of embryo with good quality ;endocrine disorder(Hypothyroidism ,diabetes); poor respond er(less and equal 3 oocyte) ;Excessive responder to ovarian stimulation (more than 20oocyte);freeze all of all embryos; previous surgery of uterine ;recurrent abortion ; sever male factor and refusal to cooperation in the study
Intervention groups
In one group, a three-day embryo is transferred and in another group five-day fetus is transferred
Main outcome variables
Clinical pregnancy rate ,chemical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N1
Registration date:2019-02-16, 1397/11/27
Registration timing:registered_while_recruiting
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing pregnancy rate in transfer of blastocyst vs cleavage stage in assisted reproductive technology
Public title
Clinical pregnancy rate in transfer of fresh embryo , 5 days vs 3 days
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uterine with normal cavity
Normal res ponder to ovarian stimulation
There are at least 5 fresh embryo
Sufficient thickness of endometrium in day 12 cycles
Exclusion criteria:
lack of embryo with good quality
Endocrine disorder(Hypothyroidism ,diabetes)
Poor respond er(less and equal 3 oocyte)
Excessive responder to ovarian stimulation (more than 20oocyte)
Freeze all of all embryos
Refusal to cooperation in the study
previous surgery of uterine
Recurrent abortion
Sever male factor
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
220
Randomization (investigator's opinion)
Randomized
Randomization description
The random list is using the PASS software.The type of randomization is simple . The analyst and doctor will be unaware of the intervention and control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher does not know how to randomize .The Embryologist chooses patients according to random numbers in each group.Patient and evaluator of the results are not known from the assigned group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of Medical sciences Ethics committee
Street address
Mashhad University of Medical Sciences, Mashhad University of Medical Sciences,University Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
617.IR.MUMS.MEDICAL.REC.1397
Health conditions studied
1
Description of health condition studied
Transfer of fresh embryo in assisted reproductive technology
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
6 weeks after embryo transfer
Method of measurement
sonography
2
Description
Chemical pregnancy rate
Timepoint
2weeks after embryo transfer
Method of measurement
βHCG test
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
Continued pregnancy up to 12 weeks
Method of measurement
Trans vaginal Sonography
Intervention groups
1
Description
Intervention group:Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. . Oocytes incubated in IVF medium at 37 °C with 6 %CO2 and 5 % O2 in air with saturated humidity. Finally Oocytes were fertilized by either insemination (IVF) or ICSI. Embryos were cultured in sequential media . The women will be randomly divided into two groups A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan Vaginal 600 mg daily.
Category
Treatment - Other
2
Description
Control group: Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. Oocytes incubated in IVF medium at 37 °C with 6%CO2 and 5 % O2 in air with saturated humidity. Then surrounding cumulus oophorus and corona radiata cells removed for intracytoplasmic sperm injection (ICSI). Finally Oocytes were fertilized by either insemination (IVF) or ICSI. embryos were cultured in sequential media . The women will be randomly divided into two groups .A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan vaginal( utrogestan,Besins,Brussels,Belgium ) 600 mg daily.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Center
Full name of responsible person
Malihh Mahmoudinia
Street address
Milad Infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
mahmoudiniam941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen,Tafaghodi
Street address
Vice Chancellor Of Research,Mashhad University of Medical Sciences ,Mashhad University of Medical Sciences,University Avenue ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility Clinic, East Razi Street, Dah e Day Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 4021
Email
MahmoudiniaM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayyereh khadem
Position
professor of gynecology group
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3801 2607
Email
khademn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility Clinic, East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4031
Email
MahmoudiniaM@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available