Clinical Pregnancy Rate After Removal of Unsuspected Polyps

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Status and phase: Withdrawn; Phase 3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

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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