1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of pyridostigmine on controlled ovarian stimulation cycles in individuals with poor ovarian response

Protocol summary

Study aim
Determining the effect of Pyridostigmine on controlled ovarian stimulation cycles in individuals with poor ovarian response
Design
This is a phase III, randomized, single-blind, parallel-group, placebo-controlled clinical trial conducted on 110 patients.
Settings and conduct
This RCT will be conducted at the infertility and IVF clinic in Imam Khomeini Hospital, TUMS. As the patients in the intervention group are blinded to the other group type and will be separately subjected to the intervention, the intervention will be single-blind.
Participants/Inclusion and exclusion criteria
Women with a history of poor response to ovarian stimulation in previous cycles who are willing to undergo a new cycle are eligible to participate in this study. However, individuals with a body mass index greater than 30, respiratory diseases (such as asthma, chronic obstructive pulmonary disease), renal disease, slow or irregular heartbeat, a history of slow bowel movements and constipation (due to the possibility of delayed drug metabolism), or metabolic disorders, taking any other cholinergic drug and/or psychotropic medications and corticosteroids, suffering from stage III-IV endometriosis, or having a history of any allergic reactions, will not be included in this study.
Intervention groups
After obtaining informed consent, the patients will be randomly assigned to two groups, A and B. Group A or the intervention group will receive controlled ovarian stimulation treatment with Pyridostigmine at a dose of 120 mg (two 60 mg tablets) orally per day starting from day 1 of the stimulation cycle and will continue until the trigger HCG injection. Group B or the control group will receive routine treatment, which consists of daily administration of a maximum of 150 units of gonadotropin.
Main outcome variables
Retrieved Oocytes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100518003950N8
Registration date: 2023-08-05, 1402/05/14
Registration timing: prospective

Last update: 2023-08-05, 1402/05/14
Update count: 0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Mina Jafarabadei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pyridostigmine on controlled ovarian stimulation cycles in individuals with poor ovarian response
Public title
Investigating the effect of pyridostigmine in individuals with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a history of poor response to ovarian stimulation in previous cycles who are willing to undergo a new cycle.
Exclusion criteria:
BMI more than 30 Respiratory diseases (such as asthma, COPD), renal disease, slow or irregular heartbeat, a history of slow bowel movements and constipation (due to the possibility of delayed drug metabolism), or metabolic disorders. Taking any other cholinergic drug. Endometriosis, stage III-IV History of allergic reactions Taking psychotropic medications and corticosteroids
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly allocated into two groups using 4-block randomization with a 1:1 allocation ratio. The allocation will be as follows: AABB-ABBA-ABAB-BBAA-BAAB-BABA-... This allocation will continue until the desired sample size (55 participants per group) is achieved.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients in the intervention group are blinded to the other group type and will be separately subjected to the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.173

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Retrieved Oocytes
Timepoint
36 hours after receiving the ovulation induction
Method of measurement
Laboratory count

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive controlled ovarian stimulation treatment with Pyridostigmine at a dose of 120 mg (two 60 mg tablets) orally per day starting from day 1 of the stimulation cycle and will continue until the trigger HCG injection.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive routine treatment, which consists of daily administration of a maximum of 150 units of gonadotropin.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The infertility and IVF clinic in Imam Khomeini Hospital, TUMS.
Full name of responsible person
Mina Naghi Jafarabadi
Street address
Keshavarz Blvd, Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
minajaf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
6th floor., Central Organization of TUMS., Qods Ave., Keshavaraz Blvd.
City
Tehran
Province
Tehran
Postal code
1276141690
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadei
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Research Center, Imam Khomeini Hospital, Keshavarz Bulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
jafarabadi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Blvd, Immam Khomeini Hospital , vali-Asr Hospital.
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
Email
minajaf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz BlVd, Imam Hospital,Vali-Asr Hospital.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
Email
minajaf@yahoo.com
Web page address

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
No more Information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...