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Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing intrauterine contraceptive device is inadequate to be used as a medical line of treatment of dysfunctional uterine bleeding.
The investigators aim to evaluate the therapeutic effect of the intrauterine system (Metraplant-E) in the treatment of dysfunctional uterine bleeding.
Primary outcome : The investigators aim to evaluate the short term release of levonorgestrel from the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices (IUCDs). This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce MBL in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale.
Secondary outcome:
1) Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E).
3) Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when endometrial biopsy is done.
4) The amount of monthly menstrual blood loss after the insertion the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices using the following scores: bleeding index,total bleeding score and Pictorial blood loss assessment chart (PBAC).
Inclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metraplant-E First prototype | Experimental | Metraplant-E (first prototype) levonorgestrel-releasing intrauterine device |
|
| Metraplant-E second prototype | Experimental | Metraplant-E (second prototype) levonorgestrel-releasing intrauterine device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metraplant-E levonorgestrel-releasing intrauterine device | Device | Metraplant-E insertion and follow up for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of menstrual blood loss (MBL) in women with menorrhagia by means of pictorial bleeding assesment chart | This is in a trial to determine to what extent the intrauterine release of levonorgestrel would reduce menstrual blood loss (MBL) in women with menorrhagia and if the treatment would increase the body iron stores and the degree of patient satisfaction and acceptability of treatment for the patients with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histological changes in Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system (Metraplant-E) | to observe the effects of the intrauterine-released levonorgestrel on the endometrium after 6 months after the insertion of the device | 6 months |
| Hemoglobin level in blood prior to the device insertion and 6 months afterwards |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of patient satisfaction and acceptability of treatment Metraplant-E intrauterine device for the patients with dysfunctional uterine bleeding. | This will be conducted through a questionnaire offered to the women participating in this study which is designed on Likert scale. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Azzam, MD | Ain Shams University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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and to assess the effect on general condition of the patient by following up the haemoglobin level. |
| 6 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |