In this study, the effect of endometrial biopsy on increasing pregnancy rates in infertile women under IUI treatment
-Who Referred to Shariati Hospital in the year of 1397 was checked
Design
Controlled clinical trial with parallel group, double-blind, randomized (with table of random numbers)
Settings and conduct
In this study, 122 women with infertility under IUI treatment - who referred to Shariati Hospital in the year of 1397- was selected randomly and was treated with 2.5 mg letrozole tablets from day 3-7 of menstrual cycle. Endometrial biopsy randomly is done for 61 patients on their ninth day of cycle; and for 61 other patients, the biopsy will not be done. After at least one follicle reached a size of above 18-20 mm, 250cc HCG injections prescribed. 24-36 hours later, IUI done.Two weeks after the intervention, serum Beta-HCG was checked
Participants/Inclusion and exclusion criteria
Inclusion criteria included: age less than 30 years with Irregular menstruation, BMI less than 40 years, the normal uterine cavity and normal tests.
Exclusion criteria included: tubal obstruction and infertility with male factor.
Intervention groups
Group 1: Perform biopsy before intervention IUI
Group 2: IUI intervention without biopsy
The effect of Endometrial biopsy in increasing pregnancy rates in infertile women under intra uterin insemination treatment
Public title
The effect of endometrial biopsy in increasing pregnancy before intra uterin insemination treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years
irregular menstruation
BMI <30
normal Hystrosalpingography
normal pop smear
normal uterine cavity
normal FSH, normal LH, normal estradiol and TSH, normal prolactin, AMH> 1
normal sperm analysis.
Exclusion criteria:
infertility with male factor
tubal factor infertility
ovarian cysts
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was done to the study groups. Randomized random numbers were used to randomize.
Blinding (investigator's opinion)
Double blinded
Blinding description
The results evaluator and patients did not know how to intervene.code was defined for the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics of Tehran University of Medical Siences
Street address
Qods Street , Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.TUMS.REC.1394.1569
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Positive test for blood beta hCG
Timepoint
20 days After intervention
Method of measurement
Blood Test
2
Description
formation gestational sac
Timepoint
34 days after intervention
Method of measurement
Ultrasound
3
Description
Endometrial Thickness
Timepoint
2 days after intervention
Method of measurement
ultrasound
Secondary outcomes
1
Description
Abortion
Timepoint
3 months and 20 days after intervention
Method of measurement
Clinical Symptoms And Vaginal Ultrasound
Intervention groups
1
Description
For 61 patients in the intervention group endometrial biopsy is done before IUI
Category
Treatment - Other
2
Description
Control group: IUI without endometrial biopsy is performed for 61 patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Somayeh Moradpanah
Street address
Shariati Hospital , Jalal Al Ahmad Intersection , Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2421
Email
zmoradpanah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr MasoudYounesian
Street address
Qods street , Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8490 1000
Email
zmoradpanah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy Research Tehran 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
Shariati Hospital
Full name of responsible person
Somayeh Moradpanah
Position
Obstetrics and Gynecology Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shariati Hospital, Jalal Al Ahmad Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2421
Fax
Email
zmoradpanah@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Meddical Science
Full name of responsible person
Somayeh Moradpanah
Position
Obstetrics and Gynecology Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shariati Hospital, Jalal Al Ahmad Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2421
Fax
Email
zmoradpanah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Somayeh Moradpanah
Position
Obstetric and Gynecology Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shariati Hospital, Jalal Al Ahmad Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2421
Fax
Email
zmoradpanah@gmail.com
Web page address
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
No - There is not 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
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available