Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01111799
First received: April 21, 2010
Last updated: March 15, 2012
Last verified: March 2012

April 21, 2010
March 15, 2012
June 2010
September 2012   (final data collection date for primary outcome measure)
Clinical Pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Clinical Pregnancy rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01111799 on ClinicalTrials.gov Archive Site
Live birth [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Live birth [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?
Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment

It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility
  • Implantation Failure
  • Procedure: endometrial biopsy
    two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
  • Procedure: natural cycle + IUI + endometrial biopsy
    two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
  • Experimental: Clomiphene citrate + IUI + endometrial biopsy
    Clomiphene citrate + IUI + endometrial biopsy
    Intervention: Procedure: endometrial biopsy
  • No Intervention: Clomiphene citrate + IUI
  • Experimental: gonadotrophines + IUI + endometrial biopsy
    two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
    Intervention: Procedure: endometrial biopsy
  • No Intervention: gonadotrophines + IUI
  • Experimental: natural cycle + IUI + endometrail biopsy
    two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
    Intervention: Procedure: natural cycle + IUI + endometrial biopsy
  • No Intervention: natural cycle + IUI
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-38.
  • infertility.
  • patients undergoing IUI treatment.
  • at least one failed IUI cycle.

Exclusion Criteria:

  • indication for IVF treatment.
  • Known Pelvic inflammatory disease(PID).
Female
18 Years to 38 Years
No
Contact: Yuval Or, MD +97289445150 yuval_o@clalit.org.il
Contact: Leila Aliger, MD +97289445150
Israel
 
NCT01111799
004608K
No
Meir Medical Center
Meir Medical Center
Not Provided
Study Director: Yuval Or, MD Clalit health service
Meir Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP