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Evaluating the effect of dry cupping, and Aslaq capsule, on the incidence of pregnancy in patients with infertility due to polycystic ovary syndrome

Protocol summary

Study aim
Comparison of the effect of cupping, aslaq capsule, aslaq capsule with cupping, and letrozole on pregnancy rate in patients with infertility due to polycystic ovary syndrome
Design
Clinical trial with control group, with parallel groups, randomized, phase 3, on 120 patients. Statistical software R version 4.0.2 was used for randomization.
Settings and conduct
Location: Molud Infertility Center of Zahedan - In the Letrozole group, 5 mg per day, 3th to 7th of menstruation - In the cupping + letrozole group: cupping daily for 15 to 20 min from the 7th to the 14th days of mensuration + letrozole - In the aslaq capsule + Letrozole group: 2 aslaq capsules a day for 21 days from the first day of cleansing, then the capsule is stopped until menstruation occurs + Letrozole - In the cupping + aslaq capsule + Letrozole group: combination of aslaq capsule+cupping is considered+ Letrozole. For all patients on day 13 of the menstrual cycle, ultrasound is performed for following the growth of ovarian follicles. Each patient will be in the study for a maximum of 6months, unless no improvement in the parameters is seen after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: PCOs based on Rotterdam criteria and diagnosing infertility fellowship, Infertility with at least one year of unprotected intercourse, Age between 18 and 35 years Exclusion criteria: Systemic disease requires serious therapeutic interventions, premature ovarian failure, Single ovarian cyst or breast cyst Endometriosis, Pelvic Adhesions, Tube Obstruction, Tube Abnormalities, and Hyperprolactinemia, Infertility due to male factor
Intervention groups
Patients are randomly assigned to one of the following four groups: Group 1: Aslaq capsule (Touba company) + cupping + Letrozole Group 2: Aslaq capsules + Letrozole Group 3: cupping + Letrozole Group 4: Letrozole
Main outcome variables
Occurrence of pregnancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180923041093N7
Registration date: 2022-07-04, 1401/04/13
Registration timing: prospective

Last update: 2022-07-04, 1401/04/13
Update count: 0
Registration date
2022-07-04, 1401/04/13
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of dry cupping, and Aslaq capsule, on the incidence of pregnancy in patients with infertility due to polycystic ovary syndrome
Public title
Evaluating the effect of dry cupping, and Aslaq capsule, on the infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCOs based on Rotterdam criteria and diagnosing infertility fellowship Infertility with at least one year of unprotected intercourse Age between 18 and 35 years
Exclusion criteria:
Systemic disease requires serious therapeutic interventions premature ovarian failure Single ovarian cyst or breast cyst Endometriosis, Pelvic Adhesions, Tube Obstruction, Tube Abnormalities, and Hyperprolactinemia Infertility due to male factor
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to four groups is done by permuted block stratified randomization. In this way, eligible patients are first classified according to BMI, consumption or non-consumption of metformin, and regular or irregular menstruation (oligomenorrhea or amenorrhea), respectively. Then, based on the four blocks (consisting of four groups A, B, C and D) that are randomly selected from all possible modes of permutations, they are assigned to the desired group. These blocks are created using R statistical software version 4.0.2.
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
Research Ethics Committees of Zahedan University Of Medical Sciences
Street address
Dr. Hesabi Square, Persian Gulf Boulevard -
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.ZAUMS.REC.1401.105

Health conditions studied

1

Description of health condition studied
Infertility due to polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
time of pregnancy occurrence
Timepoint
After the intervention
Method of measurement
sonography or BHCG

Secondary outcomes

1

Description
Menstrual pain
Timepoint
Monthly
Method of measurement
Visual analogue scale

2

Description
The length of the menstrual cycle
Timepoint
Monthly
Method of measurement
Time interval from the first day of menstrual bleeding to the last day of menstrual bleeding in a cycle. Based on the person's response to the questionnaire

3

Description
Ovulation rate
Timepoint
Monthly
Method of measurement
Ultrasonography

4

Description
Endometrial thickness
Timepoint
Monthly - Day 13 of the menstrual cycle
Method of measurement
Ultrasonography

5

Description
Follicle growth
Timepoint
Monthly - Day 13 of the menstrual cycle
Method of measurement
Ultrasonography

6

Description
Sexual function
Timepoint
At the beginning of the intervention, three and six months after the start of the intervention
Method of measurement
Female sexual function index

Intervention groups

1

Description
Intervention group: cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the seventh day of the menstrual cycle to the fourteenth day, dry cupping under the abdomen (the area between the upper area of ​​the symphysis pubis bone - above the pubic hairline - and below the navel) will be done using four cups with a diameter of 6 cm. Patients are trained for cupping. In this way, castor oil is applied to the lower abdomen and 4 cups are placed on it, then a vacuum is created by the suction device that is provided to the patients so that the skin protrudes in the glass and becomes slightly red due to the accumulation of blood. The cups are left for 15 to 20 minutes and then gently removed. In the grouping group, if menstruation does not occur on day 35 of the cycle, the beta test is taken from the patient, and if the test is negative, cupping is performed again for 5 days, and if menstruation occurs, the stopping is stopped. If menstruation does not occur with cupping, the patient will be excluded from the study for other treatments.
Category
Treatment - Drugs

2

Description
Intervention group: Aslaq capsule+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the first day of cleansing for 21 days, one Asalq capsule in the morning, one capsule at night, then the capsule is cut until menstruation occurs and the next cycle of taking the capsule starts from the first day of cleansing the next cycle. If no menstruation occurs 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, the seventh day (seven days after discontinuation of the capsule) the capsule is started again. If menstruation does not occur after two periods of taking the capsule, the patient will be excluded from the study for other treatments.
Category
Treatment - Drugs

3

Description
Intervention group: Aslaq capsule and cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, a combination of Aslaq capsule and cupping is used. The cupping from day 7 to 14 of the menstrual cycle and the capsule are considered for 21 days from the first day of cleansing. In case of no menstruation 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, on the seventh day (seven days after discontinuation of the capsule) the capsule is started again and at the same time with the start of the capsule, the cupping is done for 5 days. At this stage, if menstruation occurs, the cupping and the capsule are cut off. If menstruation does not occur after two periods of taking the capsule with the cupping, the patient will be excluded from the study to receive other treatments.
Category
Treatment - Drugs

4

Description
Control group: letrozole - 2.5 mg tablets twice a day, 5 days in a cycle will start from the third day of menstruation. If you do not menstruate after 50 days from the start of the previous cycle, 200 mg of progesterone is prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Molud infertility center in Ali Ibn Abi Talib Hospital, Zahedan
Full name of responsible person
Marziye Ghasemi
Street address
Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 43111
Phone
+98 915 302 0601
Email
drghasemim@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
NoorMohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Doctor Hesabi Sq. Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
43463 98167
Phone
+98 54 3337 2151
Email
bakhsha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Pharmacology research center, Zahedan university of medical sciences, Hesabi square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 938 238 4249
Email
hashemifa67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali ebne Abi Taleb Hospital, Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 43111
Phone
+98 54 3329 5570
Email
drghasemim@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Pharmacology research center, Zahedan university of medical sciences, Hesabi square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5792
Email
hashmifa67@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
Not applicable
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
After the study, information about the main outcome will be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
For academic and scientific researchers only
Under which criteria data/document could be used
Only in line with the analysis and research related to the main title of this study
From where data/document is obtainable
Email to hashemifa67@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.
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