Clinical Pregnancy Rate After Removal of Unsuspected Polyps

Study Overview
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Brief Summary
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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

Official Title
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Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology

Conditions
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Infertility

Intervention / Treatment
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* Procedure: polypectomy
* Procedure: saline sonography
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal semen analysis 24 months of unprotected sexual intercourse NORMAL TVS Normal hysterosalpingogram Evidence of spontaneous ovulation No history of Pelvic inflammatory disease Polyps on saline sonography Exclusion Criteria: History of taking hormones Thyroid disorder prior hysteroscopy treatment intermenstrual blood loss.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy | Procedure: polypectomy<br>* . 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.<br>Procedure: saline sonography<br>* 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.<br>Drug: normal saline<br>* Normal saline would be injected into uterine cavity to delineate defects<br>|
| Placebo Comparator: control<br>All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls | Procedure: saline sonography<br>* 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.<br>Drug: normal saline<br>* Normal saline would be injected into uterine cavity to delineate defects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate: | number of women who get pregnancy test positive within 12 months of intervention | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyps, saline sonography, infertility