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Clinical Pregnancy Rate After Removal of Unsuspected Polyps

NCT02762097 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-11-06

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

polypectomy

. 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.

PROCEDURE

saline sonography

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.

DRUG

normal saline

Normal saline would be injected into uterine cavity to delineate defects

Sponsors & Collaborators

  • Karachi Medical and Dental College

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2020-01-30
Completion
2020-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762097 on ClinicalTrials.gov