Effect of using vaginal estrogen cream versus not using on endometrial thickness in infertile women under embryonal transfer: a single blind randomized clinical trial
Objectives: To assess the effect of using vaginal estrogen cream versus not using on endometrial thickness in infertile women under embryonal transfer
Design: A randomized clinical trial.
Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 20 to 35 years; infertility.
Exclusion criteria: Estradiol contraindication; uterus problem.
Intervention group: Conjugate vaginal estrogen cream once a day for 11 days plus estradiol tablet 6 mg once a day for 11 days
Control group: Estradiol tablet 6 mg once a day for 11 days.
Primary outcome: Measuring the endometrial thickness using sonography before intervention and on 5 and 9 and 11 days of the menstrual cycle.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The examiner will not be aware of the type of treatment, therefore the study will be run as a single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708309014N180
Registration date:2017-09-03, 1396/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using vaginal estrogen cream versus not using on endometrial thickness in infertile women under embryonal transfer: a single blind randomized clinical trial
Public title
Effect of using vaginal estrogen cream versus not using on endometrial thickness in infertile women under embryonal transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 20 to 35 years; infertility.
Exclusion criteria: Estradiol contraindication; uterus problem.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The examiner will not be aware of the type of treatment, therefore the study will be run as a single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.UMSHA.REC.1395.251
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Measuring the endometrial thickness
Timepoint
before intervention and on 5 and 9 and 11 days of the menstrual cycle
Method of measurement
using sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conjugate vaginal estrogen cream once a day for 11 days plus estradiol tablet 6 mg once a day for 11 days
Category
Treatment - Drugs
2
Description
Control group: Estradiol tablet 6 mg once a day for 11 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nazanin Sahebi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
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
Fatemieh Hospital
Full name of responsible person
Nazanin Sahebi
Position
Medical Student
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
nazaninsahebi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Nazanin Sahebi
Position
Medical Student
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
nazaninsahebi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)