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

Infertility Clinical Trial

Official title:

Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01111799
• Other study ID #: 004608K
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2010
• Last updated: March 15, 2012
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Yuval Or, MD
• Phone: +97289445150
• Email: yuval_o[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Implantation Failure
• Infertility

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Remez women medical center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy rate		1 year	No
Secondary	Live birth		2 years	No