Treatment of infertility in women with polycystic ovaries (PCOS) with the herbal medicine of calcitropin
Design
Clinical trial with control group, parallel groups, triple- blind, random groups
Settings and conduct
In the infertility ward at the Alavi Hospital, via triple blind and random sampling
Participants/Inclusion and exclusion criteria
Women aged 20-45 years, i.e., first pregnancy, oliguria or menstrual disorders, clinical signs such as hyperandrogenism, no history of drug use for menstrual disorders in the last three months without any signs of infertility and no male factor in the partner
Also, no history of neurological diseases. In case the above criteria are absent, the sample will be removed from the study.
Intervention groups
Metformin
Main outcome variables
Infertility treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140422017388N3
Registration date:2020-09-22, 1399/07/01
Registration timing:retrospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Sousan Houshmandi
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2006
Email address
s.houshmandi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Impact of Calcitropin and Metformin as Adjunctive Therapy in Treating infertility in Women with Polycystic Ovary Syndrome
Public title
Comparison of the Impact of Metformin and Calcitropin in Treating Polycystic Ovaries in Infertile Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20-45 years
I.e., first pregnancy, oliguria or menstrual disorders, clinical signs such as hyperandrogenism, no history of drug use for menstrual disorders in the last three months without any signs of infertility
No male factor in the partner
Exclusion criteria:
Absence of inclusion criteria
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The main researcher, health caregivers, people charged with data collection
Placebo
Not used
Assignment
Parallel
Other design features
80
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St., Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56189-53141
Approval date
2018-11-25, 1397/09/04
Ethics committee reference number
IR.RUMS.1397.142
Health conditions studied
1
Description of health condition studied
Polycystic ovaries, infertility
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Infertile women with polycystic ovaries
Timepoint
Three months after taking the drug
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Calcitrapin - People with polycystic ovary syndrome who have the inclusion criteria are placed in the intervention group and receive calcitrapin every twelve hours for three months, then after three months, they undergo ovulation induction of intrauterine insemination
Category
Other
2
Description
Control group: Ovulation induction: In the control group, people undergo metformin treatment for three months, then after this interval, they are placed under ovulation induction and intrauterine insemination. After two weeks, pregnancy tests are taken from both groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Sousan Houshmandi
Street address
Daneshgah St., After Shurabil Lake - Ardabil University of Medical Sciences, Education and Research Deputy
City
Ardabil
Province
Ardabil
Postal code
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
sousan2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Razi azar
Full name of responsible person
Habib Doshman Fekan
Street address
n the 25th km of the old Tehran Rd, Saeed Abad village, Hakim Razi Azar company, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5495119412
Phone
+98 41 3630 7193
Email
info@merspharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Razi azar
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Sousan Houshmandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ayatollah Moghaddas Ardabili Ave., Shahid Maadi St., Alavi Educational and Medical Center, Ardabil
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۳۹۷۴۱۵۶
Phone
+98 45 3324 2327
Email
sousan2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Sousan Houshmandi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshgah St, Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4799
Fax
+98 45 3353 4790
Email
sousan2020@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Sousan Houshmandi
Position
Master of Science Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshgah St., After Shurabil Lake - Ardabil University of Medical Sciences, Education and Research Deputy
City
Ardabil
Province
Ardabil
Postal code
56189-53141
Phone
+98 45 3351 0052
Fax
Email
sousan2020@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available