Comparison effect of oral Dydrogestrone with vaginal progesterone on the success of intrauterine sperm injection in patients with unexplained infertility
Design
This study is a double blind randomized clinical trial study of Phase 3. Accidentally patients are divided between three groups with random allocation software. In this study.
Settings and conduct
This double blind clinical trial study will be conducted in 2021 and 2021 in Al-Shahid Beheshti hospital in Isfahan. In this study, 210 women with unexplained infertility were studied in 3 groups of 70 recipients receiving oral Dydrogesterone, vaginal Progesterone, and Placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria include women with unexplained infertility, indications for treatment of intrauterine sperm injection,maximum 45 years old and patient consent to participate in the study. Consumption of other interfering treatment regimens is also considered as a criterion for non-entry.
Intervention groups
Group 1: Patients undergoing intrauterine sperm injection with oral administration of Dydrogestrone oral tablets in the amount of 10 mg for 16 days
Group 2: Patients undergoing intrauterine sperm injection with 400 mg progesterone vaginal suppository, manufactured by Abureihan Iran Company, one overnight for 16 days
Group 3: Patients undergoing intrauterine sperm injection with oral medication for 16 days
Main outcome variables
Fertility success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N47
Registration date:2020-06-10, 1399/03/21
Registration timing:prospective
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
compression of oral Dydrogestrone with vaginal Progestron in IUI successfull in patient with unexplained infertility
Public title
Comparison effect of oral dydrogesterone with vaginalprogesterone in the treatment of infertility by intrauterine sperm injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Visiting women with unexplained infertility
Indications for treatment of intrauterine sperm injection
Patient's consent to participate in the study
Maximum 45 years old
Exclusion criteria:
Do other infertility treatments at the same time
Age
To 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients in two groups is done using Random Allocation Software. In this software, first the total volume of the sample enters the software and in the next step, the number of groups is specified. Software output includes a list of numbers from 1 to 210 that are randomly distributed in groups Aو B and C. Patients are divided into three groups according to the time list, according to the time list, so that the sample size reaches the required number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the type of medication they are taking. Diderotestron is marketed as the main drug and coded on the main drug and placebo, and is given to patients for use. The outcome of treatment is also checked by a gynecologist who is unaware of the type of medication being taken.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medicla Sciences, Hezarjerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MUI.MED.REC.1397.337
Health conditions studied
1
Description of health condition studied
unexplained infertility
ICD-10 code
N97.9
ICD-10 code description
unexplained infertility
Primary outcomes
1
Description
Fertility success
Timepoint
16 days after treatment
Method of measurement
Measurement of beta HCG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Infertile women treated with intrauterine sperm injection with oral administration of 10 mg oral tablets of Dydrogesterone, one tablet per night for 16 days
Category
Treatment - Drugs
2
Description
Intervention Group 2: Infertile women treated with intrauterine sperm injection with progesterone vaginal suppositories, 400 mg, one suppository per night for 16 days
Category
Treatment - Drugs
3
Description
Control group: Infertile women treated with intrauterine sperm injection with oral administration of didrogesterone placebo, one pill a night for 16 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Zeynab Navabi
Street address
Shahid Beheshti street, Motahari street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
dr.navabi88@gmaile.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?