Clinical Pregnancy Rate After Removal of Unsuspected Polyps

NCT ID: NCT02762097

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2020-01-30

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

polypectomy

Intervention Type 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.

saline sonography

Intervention Type 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.

normal saline

Intervention Type DRUG

Normal saline would be injected into uterine cavity to delineate defects

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

Group Type PLACEBO_COMPARATOR

saline sonography

Intervention Type 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.

normal saline

Intervention Type DRUG

Normal saline would be injected into uterine cavity to delineate defects

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

normal saline

Normal saline would be injected into uterine cavity to delineate defects

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karachi Medical and Dental College

OTHER

Sponsor Role lead

Responsible Party

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samia husain

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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karachiMDC

Identifier Type: -

Identifier Source: org_study_id

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