Effect of Microrelin on the size of uterus fibroma in patients undergoing hysteroscopic myoma resectio
- Conditions
- eiomyoma of uterus.Leiomyoma of uterus
- Registration Number
- IRCT201408133950N3
- Lead Sponsor
- Vice Chancellor for Research of Tehran University of Medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Size of myoma. Timepoint: 12 weeks after microrelin subscription. Method of measurement: sonography.
- Secondary Outcome Measures
Name Time Method evel of gonadotrophins and estrogen in serum. Timepoint: two and 12 weeks after microrelin subscription. Method of measurement: ELISA.;Surgeon's satisfaction. Timepoint: end of operation. Method of measurement: Visual Assessment Score.;Operation time. Timepoint: end of operation. Method of measurement: surjeon's announcement.;Absorbed fluide volume. Timepoint: end of operation. Method of measurement: fluide gathered in suction subtracted from used fluide.