Clinical Trial: Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

Brief Summary: The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

Detailed Summary:

Patients will be randomized using a list of computer generated random sample into two groups:

Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.

Timing and technique of endometrial sampling:

Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).

The procedure is as follows:

  1. Vaginal speculum to expose the uterine cervix then sterilization by saline.
  2. The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.
  3. While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.
  4. A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.

Sponsor: Al Hayat National Hospital

Current Primary Outcome:

  • Clinical pregnancy rate. [ Time Frame: one year ]
  • Miscarriage rate. [ Time Frame: one year ]
  • Multiple pregnancy rates [ Time Frame: one year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Al Hayat National Hospital

Dates:
Date Received: January 20, 2015
Date Started: February 2014
Date Completion: September 2016
Last Updated: April 4, 2016
Last Verified: April 2016