Comparison of the efficacy of metformin and inofolic in ovulation induction in patients with resistant polycystic ovarian syndrome
Design
Randomized clinical trial without control group, with parallel groups, without blinding, phase 2 on 40 patients (a random numbers table used for allocation). This table contains the numbers 0 to 9 with the probability of occurrence being approximately equal. Random allocation concealment was performed by computer.
Settings and conduct
This study was conducted on 40 patients with PCOS based on Rotterdam criteria (including two of three following criteria: anovulation, clinical or biochemical signs of hyperandrogenic, polycystic varies in ultrasound), that referred to the Infertility Clinic of Imam Khomeini Hospital in Ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: including oligomenorrhea, amenorrhea, evidence of polycystic ovaries on ultrasound, hypergnadism with or without obesity.
Exclusion criteria: Lack of patient cooperation and inability to follow treatment for 3 months.
Intervention groups
Patients were randomly assigned to two groups of metformin (receiving 1 tablet of 500 mg twice daily) and inofolic (receiving 1 sochet twice a day, half an hour before breakfast and half an hour before dinner ). Treatment was continued for 3 months
Main outcome variables
The primary outcome was comparison of follicular growth in both groups. Comparing the occurrence of biochemical pregnancy and also the number of dominant follicles was also compared between the groups as a secondary outcome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200816048427N1
Registration date:2020-10-15, 1399/07/24
Registration timing:retrospective
Last update:2020-10-15, 1399/07/24
Update count:0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Razieh Ghanbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3624 1035
Email address
12azie.gh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Comparison of the Efficacy of Metformin and Inofolic in Ovulation induction in Patients with resistant Polycystic Ovarian Syndrome
Public title
Comparison of the Efficacy of Metformin and Inofolic in Ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of Oligomenorrhoea
Presence of Amenorrhea
Presence of Polycysticovarian Evidence in Ultrasound
Hypergonadism
Lack of Response to Ovulation Induction Therapy
Exclusion criteria:
Lack of patient cooperation
Inability to follow treatment for 3 months.
Age
From 22 years old to 32 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization method, numbering of all samples starting from 01 to 40, then first 20 people selected using random numbers table are allocated to intervention A and the rest to intervention B. The researcher must first preset the direction for reading the table numbers (for example, up, down, left or right) then the researcher touches one of the numbers and moves in one of the predefined directions and records the numbers. And assigns to group A. The rest are assigned to Group B.
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 Ahvaz Jondishapur University of Medical Sciences
Street address
Ekhlas 6 Ave, Jahadgaran Alley
City
Dorud
Province
Lorestan
Postal code
۶۸۸۱۷۹۴۶۷۱
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.615
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome(PCOS)
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
follicular growth
Timepoint
The size of the follicles at the beginning of treatment (before the intervention) and 90 days after the start of metformin and inofolic
Method of measurement
transvaginal ultrasonography
Secondary outcomes
1
Description
number of dominant follicles
Timepoint
At the beginning of the study (before the intervention) and 90 days after the start of metformin and inofolic
Method of measurement
transvaginal ultrasonography
Intervention groups
1
Description
First Intervention group: group of metformin (receiving 1 tablet of 500 mg twice daily)
Category
Treatment - Drugs
2
Description
Second Intervention group: group of inofolic (receiving 1 sochet twice a day, half an hour before breakfast and half an hour before dinner )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Medical Center of Ahvaz
Full name of responsible person
Razieh Ghanbarzadeh
Street address
Azadegan Ave., Imam Khomeini Medical Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2118
Fax
+98 61 3222 5763
Email
12azie.gh@gmail.com
Web page address
https://himam.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Ghanbarzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7570
Fax
+98 61 3336 1514
Email
12azie.gh@gmail.com
Web page address
https://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
70
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
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Ghanbarzadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekhlas 6 Ave, Jahadgaran Alley
City
Dorud
Province
Lorestan
Postal code
۶۸۸۱۷۹۴۶۷۱
Phone
+98 61 3624 1035
Fax
Email
12azie.gh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Ghanbarzadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekhlas 6 Ave, Jahadgaran Alley
City
Dorud
Province
Lorestan
Postal code
۶۸۸۱۷۹۴۶۷۱
Phone
+98 61 3624 1035
Fax
Email
12azie.gh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Ghanbarzadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekhlas 6 Ave, Jahadgaran Alley
City
Dorud
Province
Lorestan
Postal code
۶۸۸۱۷۹۴۶۷۱
Phone
+98 61 3624 1035
Fax
Email
12azie.gh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD