Clinical Pregnancy Rate After Removal of Unsuspected Polyps

Phase 3

Withdrawn

• Conditions: Infertility
• Interventions: Procedure: polypectomy; Procedure: saline sonography; Drug: normal saline

• Registration Number: NCT02762097
• Lead Sponsor: Karachi Medical and Dental College

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-30
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Study Start: 2017-01-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-03
• Last Update Posted: 2018-11-06
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	saline sonography	All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy
intervention	polypectomy	All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy
intervention	normal saline	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	saline sonography	All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls
control	normal saline	All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate:	12 months	number of women who get pregnancy test positive within 12 months of intervention