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Clinical Pregnancy Rate After Removal of Unsuspected Polyps

K

Karachi Medical and Dental College

Status and phase

Withdrawn
Phase 3

Conditions

Infertility

Treatments

Procedure: polypectomy
Procedure: saline sonography
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02762097
karachiMDC

Details and patient eligibility

About

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

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

intervention
Experimental group
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
Treatment:
Drug: normal saline
Procedure: polypectomy
Procedure: saline sonography
control
Placebo Comparator group
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
Treatment:
Drug: normal saline
Procedure: saline sonography

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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