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Study stopped due to similar case control study already completed
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Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Half of the women would have these polyps removed after their consent and the other half who would not consent would not undergo any such intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy |
|
| control | Placebo Comparator | All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polypectomy | Procedure | . During the second visit after she consents to removal of polyp revealed on prior saline sonography, a dilatation and curettage would be performed under ultrasound guidance and after successful removal of polyp (polypectomy) saline sonography would be repeated to ensure completeness of removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate: | number of women who get pregnancy test positive within 12 months of intervention | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| saline sonography | Procedure | saline infusion sonography (SIS) on 8th to 11th day of menstrual cycle. On the day of admission SIS will be performed in an outpatient setting .Taking all aseptic measures a speculum will be inserted vaginally and up to 20 ml of sterile saline solution will be infused into the uterine cavity through a cervical foley's catheter of 5 french to distend the endometrial cavity. A transvaginal transducer will be used to scan the uterine cavity. In case the patient has polyps she would be offered removal under general anaesthesia on a subsequent visit as a day case procedure. |
|
| normal saline | Drug | Normal saline would be injected into uterine cavity to delineate defects |
|