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Clinical Trials/NCT02762097
NCT02762097
Withdrawn
Phase 3

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

Karachi Medical and Dental College0 sitesJanuary 30, 2017

Overview

Phase
Phase 3
Intervention
polypectomy
Conditions
Infertility
Sponsor
Karachi Medical and Dental College
Primary Endpoint
Clinical pregnancy rate:
Status
Withdrawn
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 30, 2017
End Date
January 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Karachi Medical and Dental College
Responsible Party
Principal Investigator
Principal Investigator

samia husain

research assistant

Karachi Medical and Dental College

Eligibility Criteria

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.

Arms & Interventions

intervention

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

intervention

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: saline sonography

intervention

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

control

All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls

Intervention: saline sonography

control

All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls

Intervention: normal saline

Outcomes

Primary Outcomes

Clinical pregnancy rate:

Time Frame: 12 months

number of women who get pregnancy test positive within 12 months of intervention

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