Clinical Pregnancy Rate After Removal of Unsuspected Polyps

NCT02762097 | Withdrawn Phase 3

• 1 other identifier: karachiMDC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Infertility

Keywords

polyps; saline sonography; infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate:

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

  12 months

Study Arms (2)

intervention

EXPERIMENTAL

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; Procedure: saline sonography; Drug: normal saline

control

PLACEBO COMPARATOR

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; Drug: normal saline

Interventions

polypectomy PROCEDURE

. 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.

intervention

saline sonography PROCEDURE

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.

control; intervention

normal saline DRUG

Normal saline would be injected into uterine cavity to delineate defects

control; intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal semen analysis
• months of unprotected sexual intercourse
• NORMAL TVS
• Normal hysterosalpingogram
• Evidence of spontaneous ovulation
• No history of Pelvic inflammatory disease
• Polyps on saline sonography

You may not qualify if:

• History of taking hormones
• Thyroid disorder
• prior hysteroscopy treatment
• intermenstrual blood loss.

Sponsors & Collaborators

• Karachi Medical and Dental College: lead

MeSH Terms

Conditions

Infertility; Polyps

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 4, 2016
• Study Start: January 30, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: November 6, 2018

Record last verified: 2018-11