The purpose of this study is to determine the effect of traditional medicine products on the success of Intrauterine Insemination (IUI), and it is a non-randomized clinical trial with a historical control group; not blind; without placebo; Trial phase:1-2;The study population: infertile women referred to Milad infertility center of Mashhad, Inclusion criteria: Age between 20 to 40 years; Infertility due to anovulation, male factor infertility and unexplained infertility; Infertility below 15 years; Sperm count over 5 million; Normal hormone tests, Exclusion criteria :Body Mass Index (BMI) more than 35; Follicle diameter unsuitable for injection of Human Chorionic Gonadotropin (HCG); Endometriosis, Target sample size 432,Both intervention and control groups from 3th to 5th day of menses will be received Clomiphene or letrozole for 5 days and days 6, 7 and 8 of menses Human Menopausal Gonadotropin (HMG) or GONALF will be received. On the ninth day, sonography will be done. If found any follicles more or equal 18 mm at 12 to 14 cycles ,5000 units of HCG will be injected and after 36 hours IUI will be done. Intervention group: From 7th day of menstruation until the day of IUI, Combination products (1%) containing honey and Mace (the dried aril of Myristica fragrans Houtt), will be used into vagina with applicator once per night. Control groups: only IUI will be done without placebo. Primary outcome: Chemical and clinical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111130827N1
Registration date:2017-10-29, 1396/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Maryam Kavousi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3726 5558
Email address
kavousim921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional medicine products on the success of Intrauterine Insemination (IUI) in infertile women
Public title
The effects of preparations of traditional medicine in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women candidates for Intrauterine Insemination (IUI) (Infertility due to anovulation, male factor infertility and unexplained infertility) ; All patients are first IUI; Age between 20 and 40 years; Infertility below 15 years; Sperm count over 5 million sperm per milliliter after preparation; Normal hormone tests; The uterus is normal in Hysterosalpingography (HSG) and at least has one open Fallopian tube
exclusion criteria: Body Mass Index (BMI) more than 35; Follicle diameter unsuitable for injection of Human Chorionic Gonadotropin (HCG); Endometriosis
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
432
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences, Central Building of Mashhad University of Medical Sciences, Golestan Crossroads, Daneshgah Ave.
City
Mashhad
Postal code
13944-91388
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.MUMS.REC.1395.487
Health conditions studied
1
Description of health condition studied
Infertility due to anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
2
Description of health condition studied
Infertility due to male factors
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
3
Description of health condition studied
Infertility of women with unknown cause
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
16 days after intrauterine insemination
Method of measurement
Measurement of serum βHCG
2
Description
Clinical pregnancy
Timepoint
6 weeks after intrauterine insemination
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
drugs side effect
Timepoint
daily
Method of measurement
Patient reports
Intervention groups
1
Description
Control groups: Routine care
Category
Treatment - Other
2
Description
Intervention group: From 7th day of menstruation until the day that will be
done intrauterine insemination,Combination products (1%)containing honey and myristica fragrans will be used into vagina with applicator once per night.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Centre of milad
Full name of responsible person
Maryam kavousi
Street address
The infertility centre of Milad, beside the Sina hospital, The end of eastern Razi street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Cancellor for Research,Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Cancellor for Research,Mashhad University of Medical Sciences, Daneshgah Ave., Golestan Crossroads
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Cancellor for Research,Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Kavousi
Position
PhD student of Persian and Complementary Medicine
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine, university of Pardis, Azadi square
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
kavousim921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine,University of Pardis, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3884 8931
Fax
Email
Feyzabadiz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Kavousi
Position
PhD student of Persian and Complementary Medicine
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine, university of Pardis, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
+98 51 3882 9279
Email
Kavousim921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)