Protocol summary

Study aim
The main objective of this study is comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding . The study included 50 patients with complaints abnormal uterine bleeding that refer to Alzahra hospital for hysteroscopic myomectomy will be done. Patients randomly using random software list will be divided into two groups of 25 people. Patients with abnormal uterine bleeding and submucosal myoma with a diameter of 30 mm or less and zero or first grade will be incloud to this study. of All patients in both groups of informed consent will be obtained. Both groups were matched for age, gravid, parity and the number of myoma And patients with a history of underlying disease, submucosal larger than 3 cm will be excluded. Random selection will be done by a nurse, that aware of the details of an investigation. Doctors and patients to selected groups will be blind. After random selection of patients by the respective resident, the first group of 100 mg of natural micronized progesterone capsules called Utrogestan will be used , from the first day of the period for 30 days, two capsules totaling 200 mg when sleeping 3 hours from the last meal with a glass of water will be used. In the second group 2 months before hysteroscopy, the injection of muscle will be 3.75 mg of dipyriline ampoule as a GnRH agonist compound on day 21 of the period to two doses of 28 days. The first group will be admitted to the surgery on the last day of Utrogestan and the second group will be 4 weeks after the second injection of GnRH. In this study, the changes of hemoglobin as the primary outcome and duration of surgery and the success rate in Myomectomy, is considered secondary outcome.
Design
The study included 50 patients with complaints abnormal uterine bleeding that refer to Alzahra hospital for hysteroscopic myomectomy will be done.Then, patients were randomly divided into two control 1 and control 2.
Settings and conduct
The main objective of this study is comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding . The study included 50 patients with complaints abnormal uterine bleeding that refer to Alzahra hospital for hysteroscopic myomectomy will be done. Patients randomly using random software list will be divided into two groups of 25 people. Patients with abnormal uterine bleeding and submucosal myoma with a diameter of 30 mm or less and zero or first grade will be incloud to this study. of All patients in both groups of informed consent will be obtained. Both groups were matched for age, gravid, parity and the number of myoma And patients with a history of underlying disease, submucosal larger than 3 cm will be excluded. Random selection will be done by a nurse, that aware of the details of an investigation. Doctors and patients to selected groups will be blind. After random selection of patients by the respective resident, the first group of 100 mg of natural micronized progesterone capsules called Utrogestan will be used , from the first day of the period for 30 days, two capsules totaling 200 mg when sleeping 3 hours from the last meal with a glass of water will be used. In the second group 2 months before hysteroscopy, the injection of muscle will be 3.75 mg of dipyriline ampoule as a GnRH agonist compound on day 21 of the period to two doses of 28 days. The first group will be admitted to the surgery on the last day of Utrogestan and the second group will be 4 weeks after the second injection of GnRH. In this study, the changes of hemoglobin as the primary outcome and duration of surgery and the success rate in Myomectomy, is considered secondary outcome.
Participants/Inclusion and exclusion criteria
Patients with abnormal uterine bleeding and submucosal myoma with a diameter of 30 mm or less and zero or first grade will be incloud to this study
Intervention groups
En Intervention group 1 : A 100 mg capsule of natural micronized progesterone called Utrogestan will be used, starting from the first day of the period for 30 days, two capsules of 200 mg will be used at bedtime with 3 hours from the last meal with a glass of water. En Intervention group 2: Intramuscular injection of 3.75 mg of diafililic ampoule as a GnRH agonist compound will be used on day 21 of the period two dose intervals of 28 days for 2 months prior to the hysteroscopy. .
Main outcome variables
En The hemoglobin concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110523006563N3
Registration date: 2018-01-04, 1396/10/14
Registration timing: prospective

Last update: 2018-01-04, 1396/10/14
Update count: 0
Registration date
2018-01-04, 1396/10/14
Registrant information
Name
Mehri Jafari Shobeiri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
jafarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding
Public title
comparative study of natural micronized progestrone and gonadotropin-releasing hormone agonist in the control of bleeding during hysterescopic myomectomy in women with abnormal uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with abnormal uterine bleeding Patients with submucosal myoma with a diameter of 30 mm or less and zero or first grade
Exclusion criteria:
: Patients with a history of heart disease; Hepatic; Diabetes; Thromboembolism; Cancer of the uterus and cervix; Submucosal leiomyoma larger than 3 cm; Uterine septum; pregnant women; Severe bleeding; Anti coagulation therapy
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will randomly be divided into two groups using the Randlist version 1, 2, Dattng CmbH, Tubingen Germany software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Random selection will be done by a nurse, that aware of the details of an investigation. Doctors and patients to selected groups will be blind.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2017-11-14, 1396/08/23
Ethics committee reference number
IR.TBZMED.REC.1396.703

Health conditions studied

1

Description of health condition studied
Abnormal uterine and vaginal bleeding
ICD-10 code
ICD-10
ICD-10 code description
Other abnormal uterine and vaginal bleeding

Primary outcomes

1

Description
The hemoglobin concentration
Timepoint
Six hours after surgery
Method of measurement
Blood test

Secondary outcomes

1

Description
Duration of surgery
Timepoint
After surgery
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group 1 : A 100 mg capsule of natural micronized progesterone called Utrogestan will be used, starting from the first day of the period for 30 days, two capsules of 200 mg will be used at bedtime with 3 hours from the last meal with a glass of water.
Category
Treatment - Drugs

2

Description
Intervention group 2: Intramuscular injection of 3.75 mg of diafililic ampoule as a GnRH agonist compound will be used on day 21 of the period two dose intervals of 28 days for 2 months prior to the hysteroscopy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Mehri Jaefari Shobeiri
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahhroudin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com

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
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