Endometrial Curettage Before Embryo Transfer

August 20, 2006 updated by: HaEmek Medical Center, Israel

Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer

Studies have shown that endometrial sampling in the month prior to embryo transfer may increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has been suggested that local injury to the endometrium doubles the rate of implantation and successful pregnancies in IVF patients.

Purpose

  1. To determine whether performing curettage the month prior to embryo transfer (ET) increases the chance of embryo implantation.
  2. To study molecular attributes of the endometrium taken at curettage and to compare them to those cycles resulting in pregnancy and those which do not result in pregnancy.

Samples will be grown as primary culture in the research laboratory and possible molecular markers and attachment assays for endometrial receptivity will be studied.

Patient selection: Patients undergoing IVF or IVF-ICSI at Ha'Emek medical center/ IVF unit. Woman over 35 years of age will be excluded since implantation failure is more likely to be due to genetic, chromosomal or cytoplasmic aberrations in their oocytes.

Proposed protocol:

  1. Informed consent obtained from prospective candidates.

  2. Participants randomly divided to three groups

    1. Control group
    2. Hysteroscopy and curettage performed on days 15-17 of menstrual cycle
    3. Hysteroscopy and curettage performed on days 19-22 of menstrual cycle
  3. After the following menses an IVF, IVF-ICSI, or frozen embryo cycle is performed according to the unit's standard protocols.
  4. The primary end point of the study will be the implantation rate after ET and the expression of possible molecular markers for endometrial receptivity in the pregnant patients.

Study Type

Interventional

Enrollment (Anticipated)

90

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
      • Afula, Israel, 18101
        • Recruiting
        • Department of Obstetrics and gynecology, HaEmek Medical Center
        • Principal Investigator:
          • Joel Geslevich, MD
        • Sub-Investigator:
          • Amir Weiss, MD
        • Principal Investigator:
          • Shlomit Goldman, DSc
        • Principal Investigator:
          • Eliezer Shalev, 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 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent
  • In-vitro fertilization candidate
  • Normal blood coagulation

Exclusion Criteria:

  • Anemia (hemoglobin under 10 mg/dl)
  • Abnormal maternal karyotype
  • Thrombocytopenia under 140,000
  • Any contraindication to hysteroscopy or in-vitro fertilization

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pregnancy rate
Implantation rate
Endometrial receptivity

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Collaborators

Technion, Israel Institute of Technology

Investigators

  • Principal Investigator: Joel Geslevich, MD, HaEmek Medical Center
  • Study Chair: Eliezer Shalev, HaEmek Medicak Center and Technion, Israel Institute of Technology
  • Study Director: Shlomit Goldman, HaEmek Medical Center

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

December 1, 2005

Study Registration Dates

First Submitted

August 20, 2006

First Submitted That Met QC Criteria

August 20, 2006

First Posted (ESTIMATE)

August 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2006

Last Update Submitted That Met QC Criteria

August 20, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3280105
  • Ministry of Heath:920050038
  • Genetics committee: 2005-061

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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