Abnormal Uterine Bleeding (Hypermenorrhea / Menorrhagia).
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women diagnosed with menorrhagia (hypermenorrhea) due to uterine fibroid or endometrial polyp who are candidates for hysteroscopy Age between 20 and 55 years Menstrual bleeding lasting more than 7 days with abnormal uterine bleeding at irregular intervals
Exclusion criteria
Exclusion criteria: Presence of gastrointestinal disorders or any chronic disease requiring long-term treatment Pregnancy or breastfeeding History of immune system–related diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures include reduction in menstrual bleeding severity assessed by the Pictorial Blood Loss Assessment Chart (PBAC), reduction in the duration of menstrual bleeding, and improvement in quality of life. Timepoint: Outcome variables are measured at three time points: at baseline before the intervention, at the end of the second menstrual cycle following the intervention, and 60 days after completion of the intervention as a follow-up assessment. Method of measurement: Bleeding severity is assessed using the Pictorial Blood Loss Assessment Chart (PBAC), bleeding duration is recorded as the number of menstrual days, quality of life is evaluated using a standardized questionnaire, and laboratory variables are measured by blood tests (CBC, PT, INR, fibrinogen, and serum creatinine). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome variables include changes in hematological parameters related to anemia (CBC including hemoglobin, hematocrit, red blood cell count, and platelet count), coagulation parameters (PT, INR, and fibrinogen) to assess hemostatic effects and safety, and changes in serum creatinine levels to evaluate potential treatment-related toxicity. Timepoint: Measurements of variables are performed at three time points: before the start of the intervention (baseline), at the end of the second menstrual cycle after receiving the intervention, and 60 days after the end of the intervention as a follow-up period. Method of measurement: Bleeding severity is assessed using the Pictorial Blood Loss Assessment Chart (PBAC), bleeding duration is measured by recording the number of menstrual days, quality of life is evaluated using a standardized questionnaire, and laboratory parameters are assessed through blood tests including CBC, PT, INR, fibrinogen, and serum creatinine. | — |
Countries
Iran (Islamic Republic of)
Contacts
Iranian academic center for education culture and research