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

Primary Purpose

Infertility, Implantation Failure

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

endometrial biopsy

endometrial biopsy

natural cycle + IUI + endometrial biopsy

Sponsored by

Meir Medical Center

About this trial

This is an interventional treatment trial for Infertility focused on measuring endometrial biopsy, implantation, uterine receptivity, infertility, controled ovarian hyperstimulation, intra uterine insemination

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Remez women medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Clomiphene citrate + IUI + endometrial biopsy

Clomiphene citrate + IUI

gonadotrophines + IUI + endometrial biopsy

gonadotrophines + IUI

natural cycle + IUI + endometrail biopsy

natural cycle + IUI

Arm Description

Clomiphene citrate + 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.

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.

Outcomes

Primary Outcome Measures

Clinical Pregnancy rate

Secondary Outcome Measures

Live birth

Full Information

NCT ID

First Posted

April 21, 2010

Last Updated

March 15, 2012

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01111799

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Implantation Failure

Keywords

endometrial biopsy, implantation, uterine receptivity, infertility, controled ovarian hyperstimulation, intra uterine insemination

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clomiphene citrate + IUI + endometrial biopsy

Arm Type

Experimental

Arm Description

Clomiphene citrate + IUI + endometrial biopsy

Arm Title

Clomiphene citrate + IUI

Arm Type

No Intervention

Arm Title

gonadotrophines + IUI + endometrial biopsy

Arm Type

Experimental

Arm Description

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.

Arm Title

gonadotrophines + IUI

Arm Type

No Intervention

Arm Title

natural cycle + IUI + endometrail biopsy

Arm Type

Experimental

Arm Description

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.

Arm Title

natural cycle + IUI

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

endometrial biopsy

Intervention Description

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 Type

Procedure

Intervention Name(s)

endometrial biopsy

Intervention Description

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 Type

Procedure

Intervention Name(s)

natural cycle + IUI + endometrial biopsy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinical Pregnancy rate

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Live birth

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuval Or, MD

Phone

+97289445150

Email

yuval_o@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Leila Aliger, MD

Phone

+97289445150

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuval Or, MD

Organizational Affiliation

Clalit health service

Official's Role

Study Director

Facility Information:

Facility Name

Remez women medical center

City

Rehovot

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuval Or, MD

Phone

+97289445150

Email

yuval_o@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Ayelet Mokasey

Phone

+97589445150

Email

ayeletmo@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Yuval Or, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12798877

Citation

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. doi: 10.1016/s0015-0282(03)00345-5.

Results Reference

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

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