GnRH agonist are available as base, acetate, diacetate or ambonate. According to existing limitations in medical market in Iran it is supposed to focus on domestic production. No other study is done on the effect of this group of drugs on myoma size in Iran. This is a randomized clinical trial. In the age range of 18 to 50 years (all pre menopausal) patients candidate for hysteroscopic myoma resection are randomly divided into two groups of treatment and control ( n= 30 for each group). Intervention is using microrelin in treatment group. Treatment is started in first 5 days of menstrual cycle by 3.7 mg depot ampule and is repeated for three consecutive cycles. Randomization in done by a nurse in clinic using random blocks. Serum levels of FSH, LH and estradiol are measured in weeks 0, 2 and 12 after beginning of the study. The size of myoma are measured using sonography before microrelin administration and before surgery. Feasibility of myoma resection, operation time recorded by the surgeon and the volume of fluid absorption during the operation are compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408133950N3
Registration date:2014-11-22, 1393/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-22, 1393/09/01
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
Vice Chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-08-31, 1393/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect off Microrelin (GnRH agonist) on uterine fibroma
Public title
Effect of Microrelin on the size of uterus fibroma in patients undergoing hysteroscopic myoma resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Be a pre-menopausal woman between 18 and 50 years, have indication of surgical myomectomy due to any complain, Less than 2 myomas with the diameter of 2- 4 Cm which are totally intracavitary or have a myometrial expansion less than 50%, If of childbearing potential the subject must be practicing a non-hormonal method of contraception, BMI ≥ 18 and ≤ 40.
Exclusion Criteria: Indication of emergent surgery, history of or current uterine cervical, ovarian or breast cancer, current endometrium atypical hyperplasia or adenocarcinoma, a known severe coagulation disorder, has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist, Has a history of or known current osteoporosis, abnormal hepatic function at study entry, a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study, a current (within twelve months) problem with alcohol or drug abuse, is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 research deputy, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods building, Keshavarz blvd., Tehran.
City
Tehran
Postal code
Approval date
2014-07-20, 1393/04/29
Ethics committee reference number
92-03-39-23336
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
size of myoma
Timepoint
12 weeks after microrelin subscription
Method of measurement
sonography
Secondary outcomes
1
Description
level of gonadotrophins and estrogen in serum
Timepoint
two and 12 weeks after microrelin subscription
Method of measurement
ELISA
2
Description
Surgeon's satisfaction
Timepoint
end of operation
Method of measurement
Visual Assessment Score
3
Description
Operation time
Timepoint
end of operation
Method of measurement
surjeon's announcement
4
Description
Absorbed fluide volume
Timepoint
end of operation
Method of measurement
fluide gathered in suction subtracted from used fluide
Intervention groups
1
Description
intervention is using microrelin in treatment group. Treatment is started in first 5 days of menstrual cycle by 3.7 mg depot ampule and is repeated for three consecutive cycles.
Category
Treatment - Drugs
2
Description
Control Group: no treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive Health Research Center, Tehran University of medical Sciences
Full name of responsible person
Mina Jafarabadi
Street address
Reproductive Health Research Center, Emam Hospital Complex, Keshavarz Blvd.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical sciences
Full name of responsible person
Mrs Mostufi
Street address
Qods building, Keshavarz Blvd.,
City
Tehran
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 of Tehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Reproductive Health research center
Full name of responsible person
Mina Jafarabadi
Position
M.D.
Other areas of specialty/work
Street address
Emam Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
jafarabadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Mina Jafarabadi
Position
M.D.
Other areas of specialty/work
Street address
Emam Hospital, Keshavarz Blvd.,
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
jafarabadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Fedyeh Haghollahi
Position
reseach expert
Other areas of specialty/work
Street address
Reproductive Health Research Center, Imam Hospital, Keshavarz BlVd.,
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)