History
# Registration date Revision Id
2 2023-02-13, 1401/11/24 255909
1 2022-12-04, 1401/09/13 247783
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Determination of the effect of low-dose aspirin administration on the success rate of ovulation induction in women with polycystic ovary syndrome.
Design
A clinical trial with parallel groups, double-blind, randomized, on 80 patients. Blocks of 4 were used for randomization.
Settings and conduct
Patients suffering from polycystic ovary syndrome disease with the inability to ovulate (both primary and secondary) referred to the women's clinic of Ba'ath Sanandaj Hospital in 1401 who meet the inclusion criteria and do not meet the exclusion criteria.
Participants/Inclusion and exclusion criteria
Enclusion criteria: age 20 to 35 years, body mass index less than 30 kg/m2, suffering from polycystic ovary according to Rotterdam criteria. Exclusion criteria: other causes of infertility, male factor, abnormal thyroid function tests, abnormal prolactin levels, diabetes, the anatomical disorder in hysterosalpingography or laparoscopy, endometriosis.
Intervention groups
The first group: recipients of clomiphene citrate with a dose of 50 to 150 mg from the day of the 3rd cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study. The second group: received letrozole at a dose of 5 to 7.5 mg from day 3 of the cycle to 3 months after ovulation + a placebo daily until pregnancy or the end of the study. The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study The fourth group: recipients of letrozole at a dose of 5 to 7.5 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or the end of the study.
Main outcome variables
pregnancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221112056477N1
Registration date: 2022-12-04, 1401/09/13
Registration timing: prospective

Last update: 2022-12-04, 1401/09/13
Update count: 1
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Hosna Liravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 1966 7761
Email address
liravihosna@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of low-dose aspirin on the success rate of ovulation induction in women with polycystic ovary syndrome
Public title
The effect of low-dose aspirin on the success rate of ovulation induction in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 35 years Body mass index less than 30 kg/m2 Suffering from the polycystic ovary, according to Rotterdam criteria
Exclusion criteria:
Other causes of infertility Male factor Abnormal thyroid function tests Abnormal prolactin levels Diabetes Anatomical disorder in hysterosalpingography or laparoscopy Endometriosis
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
More than 1 sample in each individual
Number of samples in each individual: 1
Each patient will receive one drug plus placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that there are 4 groups under investigation and each group receives one of A, B, C, or D treatments 4 random blocks are formed as follows: ABCD, ACBD, ADCB, ADBC, ACDB, ABDC, BACD, BCAD, BDCA, BDAC, BCDA, BADC, CBAD, CBDA, CABD, CADB, CDAB, CDBA, DBCA, DBAC, DCBA, DCAB, DABC, DACB, Each time and for every 4 new patients who will enter the study, one of the above blocks will be randomly selected, and based on the order in the selected block, they will receive one of the A, B, C, or D treatments.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The patients and the main researcher do not know the type of treatment received by the groups. The statistical analysis will be done by another researcher who is unaware of the type of treatment received by the different groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Besat Hospital, Department of Obstetrics and Gynecology, Sanandaj, Kurdistan, Iran
City
sanandaj
Province
Kurdistan
Postal code
6619667761
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.MUK.REC.1400.236

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Ovulation induction
Timepoint
On the 14th day of the menstrual cycle and Every day for the next two weeks
Method of measurement
Serum levels of human chorionic gonadotropin

Secondary outcomes

1

Description
pregnancy
Timepoint
Day 14 of the cycle
Method of measurement
Transvaginal ultrasound

2

Description
Do Quitos
Timepoint
Three times a week
Method of measurement
Transvaginal ultrasound

3

Description
Measurement of human chorionic gonadotropin-beta serum level
Timepoint
two weeks later
Method of measurement
Serum test

4

Description
gestational sac
Timepoint
Six weeks later
Method of measurement
Transvaginal ultrasound

Intervention groups

1

Description
Intervention group: The first group: recipients of clomiphene citrate with a dose of 50 to 150 mg from the day of the 3rd cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study.
Category
Treatment - Drugs

2

Description
Intervention group: The second group: receiving letrozole at a dose of 5 to 7.5 mg from day 3 of the cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study.
Category
Treatment - Drugs

3

Description
Intervention group: The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study
Category
Treatment - Drugs

4

Description
The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Liravi Hosna
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
7184877699
Phone
+98 87 3328 5911
Email
liravihosna@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khaled Rahmani
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Liravi Hosna
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6619667763
Phone
+98 87 3328 5912
Email
liravihosna@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Liravi Hosna
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
7184877699
Phone
+98 87 3328 5911
Email
liravihosna@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Liravi Hosna
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
7184877699
Phone
+98 87 3328 5911
Email
liravihosna@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data will be provided to the requestors without mentioning the personal characteristics of the research participants.
When the data will become available and for how long
After the end of the research and confirmation of the obtained results and obtaining permission from the university, the information will be provided.
To whom data/document is available
Government and private research institutes and people who are interested in research in the studied field.
Under which criteria data/document could be used
In order to continue the research and complete the obtained protocol.
From where data/document is obtainable
Research assistant of the faculty
What processes are involved for a request to access data/document
The request will be submitted to the research vice-chancellor of the faculty. If approved, it will be sent to the supervisor, and if approved, the information will be provided to the applicant.
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