Clinical Pregnancy Rate After Removal of Unsuspected Polyps

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02762097

Enrollment

Registered

2016-05-04

Start date

2017-01-30

Completion date

2020-01-30

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

polyps, saline sonography, infertility

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

Interventions

PROCEDUREpolypectomy

. 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.

PROCEDUREsaline 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.

DRUGnormal saline

Normal saline would be injected into uterine cavity to delineate defects

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical pregnancy rate:	12 months	number of women who get pregnancy test positive within 12 months of intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026