To evaluate the effect of endometritis treatment on infertility in IVF and ICIS candidates
Design
In this study, 176 women who referred to Infertility Center of Besat Hospital in Sanandaj for treatment of infertility were included.The inclusion criteria for the study was 44 years old.Women older than 44 years were excluded from the study.Patients were divided randomly into intervention and control groups. For patients randomization, patients who referred to infertility clinic in a couple days were allocated in intervention group and patients who referred to infertility clinic on odd days were allocated in control group .
Settings and conduct
The study site was Sanandaj city.
Participants/Inclusion and exclusion criteria
Women with infertility and 44 years of age were enrolled in the study and women over 44 years of age were excluded.
Intervention groups
For patients in the intervention group, an endometrial biopsy was performed using pipelle curette on days 8 to 12 of the menstrual cycle. Then the cervix was washed with iodine. One month after performing endometrial biopsy the embryo was transferred. No intervention was performed for patients in control group,only embryo transfer was performed.
Main outcome variables
Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012789N17
Registration date:2018-02-03, 1396/11/14
Registration timing:registered_while_recruiting
Last update:2018-02-03, 1396/11/14
Update count:0
Registration date
2018-02-03, 1396/11/14
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
2017-11-06, 1396/08/15
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
empty
Scientific title
The effect of endometritis treatment on infertility in patients candidate for IVF and ICIS
Public title
The effect of endometritis treatment on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
44 years old women with infertility .
Exclusion criteria:
Age over 44 years
Age
From 24 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
176
More than 1 sample in each individual
Number of samples in each individual:
88
Patients with infertility
Actual sample size reached:
176
More than 1 sample in each individual
Actual sample size in each individual:
176
Patients with infertility
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into intervention and control groups using simple randomization. Patients who referred to infertility clinic in a couple days were allocated in the intervention group and patients who referred to infertility clinic on odd days were allocated in control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were unaware of grouping,but the researcher was aware of the patients grouping.
Placebo
Not used
Assignment
Other
Other design features
In this study, biopsy specimens were examined both pathologically and microbial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR. MUK. REC. 1396/213
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
Two weeks after the intervention and the sixth or seventh week in case of pregnancy
Method of measurement
Performing a pregnancy test two weeks after the last menstrual period and in case of pregnancy performing Fetal Heart Ultrasound at the sixth or seventh week of pregnancy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients in the intervention group, an endometrial biopsy was performed using pipelle curette on days 8 to 12 of the menstrual cycle. Then the cervix was washed with iodine. One month after performing endometrial biopsy the embryo was transferred .
Category
Treatment - Other
2
Description
Control group: No intervention was performed for patients in control group, only embryo transfer was performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic of Besat Hospital
Full name of responsible person
Fatemeh Tahmasebi
Street address
Keshavarz St.
City
Sanandaj
Province
Kurdistan
Postal code
66186-34683
Phone
+98 87 3328 5910
Email
f.tahmasebi@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Kurdistan University of Medical Sciencse
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Mozh.zarei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Fatemeh Tahmasebi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
f.tahmasebi@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fariba Seyedoshohadaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4674
Email
f.seyedoshohadaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fatemeh Tahmasebi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
f.tahmasebi@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data on the primary outcome (pregnancy) is for sharing.
When the data will become available and for how long
One year after the publication the data will be available.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.
From where data/document is obtainable
Dr. Fatemeh Tahmasebi
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
Mobile: 00989185220653
Email: f.tahmasebi@muk.ac.ir
What processes are involved for a request to access data/document
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email and mobile phone.