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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring polyps, saline sonography, infertility
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.
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Withdrawn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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Learn more about this trial
Clinical Pregnancy Rate After Removal of Unsuspected Polyps
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