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

March 15, 2012 updated by: Meir Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel
        • Recruiting
        • Remez women medical center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuval Or, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clomiphene citrate + IUI + endometrial biopsy
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.
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.
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.
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.
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.
NO_INTERVENTION: natural cycle + IUI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Pregnancy rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Study Director: Yuval Or, MD, Clalit Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

October 1, 2012

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004608K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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