Protocol summary

Study aim
The purpose of this study was to determine changes in the expression profile of cumulus cells in genes under the influence of different pre-incubation time of human oocytes in patients undergoing assisted reproductive cycles.
Design
In this study, the participants were randomly allocated to one of the two groups of zero and three hours of oocyte pre- incubation based on random numbers obtained from internet sites. The number of people in each group is 10, which obtain according to a study in 2009, taking into account the first type error, α = 0.05 and the second type error was β = 10%.
Settings and conduct
This study is conducted at Akbar Abadi Hospital's Infertility Clinic. Participants will be randomly assigned to one of the groups after receiving sufficient information about the study groups and the consent form, without being informed of their study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age aged 25 to 35 years, patients who are in the agonist cycle, infertile women with tubal problems, normal semen analysis according to WHO 2010 criteria Exclusion criteria: pelvic acute infection, coagulation disorder, cervicitis and vaginitis, cervix malignancy, BMI>35, endometriosis (grade 3 &4), polycystic ovarian syndrome, oocyte number less 2 and further 15
Intervention groups
Intervention group 1: The oocytes are not affected by pre- incubation. Intervention group 2: The oocytes are affected by pre-incubation for 3 hours.
Main outcome variables
Primary outcome variable: Determine the preincubation time appropriate for the human ovum, according to the molecular results for approaching the highest fertility and embryo quality. Secondary outcome variable: The determination of gene expression profiles that are involved in these pathways and can serve as a marker for the quality of oocytes and embryos.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180603039965N1
Registration date: 2018-07-27, 1397/05/05
Registration timing: registered_while_recruiting

Last update: 2018-07-27, 1397/05/05
Update count: 0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Mehdi Mehdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4569
Email address
mehdizadeh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of gene expression profile in human cumulus cells influenced by different oocyte Pre-incubation times in infertile patients under the treatment in assisted reproduction technology cycles.
Public title
The effect of oocyte per-incubation time on the cumulus gene profile
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are in the agonist cycle infertile women with tubal factor normal semen analysis according to WHO 2010
Exclusion criteria:
pelvic acute infection coagulation disorder cervicitis and vaginitis cervix malignancy BMI>35 endometriosis(grade 3 &4) polycystic ovarian syndrome oocyte number less than 2 and more than 15
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers are obtained from internet sites and patients are assigned to control and intervention groups according to these random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants do not know which intervention group they will be assigned to until the end of the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat West Highway between of Sheikh Fazlallah and Shahid Chamran intersection
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.IUMS.REC.1396.31837

Health conditions studied

1

Description of health condition studied
Determination of optimal condition to elevate invitro fertilization rate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Gene expression profile of cumulus cells
Timepoint
At the beginning and 3 hours after pre- incubation
Method of measurement
RNA Sequencing

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 0 hours oocyte pre- incubation before intracytoplasmic sperm injection
Category
Other

2

Description
Intervention group 2: 3 hours oocyte pre- incubation before intracytoplasmic sperm injection
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Abadi hospital
Full name of responsible person
Zahra Zandieh
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
1167843514
Phone
+98 21 5560 6033
Email
zandieh.z@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyyed Kazem Malakouti
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehdi Mehdizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Hemmat superhighway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2689
Email
zandieh.z@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Zandieh
Position
Hemmat superhighway
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Hemmat superhighway . faculty of medicine.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2689
Email
zandieh.z@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sadat Amjadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Hemmat superhighway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2689
Email
amjadi.fs@iums.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
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