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Clinical Pregnancy Rate After Removal of Unsuspected Polyps

Primary Purpose

Infertility

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

polypectomy

saline sonography

normal saline

About this trial

This is an interventional treatment trial for Infertility focused on measuring polyps, saline sonography, infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention

control

Arm Description

All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate:

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02762097

First Posted

April 30, 2016

Last Updated

November 3, 2018

Sponsor

Karachi Medical and Dental College

1. Study Identification

Unique Protocol Identification Number

NCT02762097

Brief Title

Clinical Pregnancy Rate After Removal of Unsuspected Polyps

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study stopped due to similar case control study already completed

Study Start Date

January 30, 2017 (Anticipated)

Primary Completion Date

January 30, 2020 (Anticipated)

Study Completion Date

January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karachi Medical and Dental College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

polyps, saline sonography, infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

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 Type

Procedure

Intervention Name(s)

polypectomy

Intervention Description

. 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 Type

Procedure

Intervention Name(s)

saline sonography

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

Normal saline would be injected into uterine cavity to delineate defects

Primary Outcome Measure Information:

Title

Clinical pregnancy rate:

Description

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

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Pregnancy Rate After Removal of Unsuspected Polyps

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