Clinical Pregnancy Rate After Removal of Unsuspected Polyps

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02762097
• Other study ID #: karachiMDC
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 30, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2018
• Source: Karachi Medical and Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karachi Medical and Dental College

Outcome

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