Clinical Pregnancy Rate After Removal of Unsuspected Polyps

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

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

Study Overview

• Status: Withdrawn
• Conditions: Infertility
• Intervention / Treatment: Procedure: polypectomy; Procedure: saline sonography; Drug: normal saline

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Placebo Comparator: 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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karachi Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2017
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: April 30, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 3, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: infertility; polyps; saline sonography
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: karachiMDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No