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Endometrial Curettage Before Embryo Transfer
This study is currently recruiting participants.
Verified by HaEmek Medical Center, Israel, August 2006
Sponsors and Collaborators: HaEmek Medical Center, Israel
Technion, Israel Institute of Technology
Information provided by: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00367367
  Purpose

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.


Condition Intervention
Infertility
Procedure: Hysteroscopy and Curettage

MedlinePlus related topics: Infertility
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Implantation rate
  • Pregnancy rate
  • Endometrial receptivity

Estimated Enrollment: 90
Study Start Date: December 2005
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.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367367

Contacts
Contact: Amir Weiss, MD 972-4-6494031 weiss_am@clalit.org.il
Contact: Joel Geslevich, MD 972-4-6495488 yoel_g@clalit.org.il

Locations
Israel
Department of Obstetrics and gynecology, HaEmek Medical Center Recruiting
Afula, Israel, 18101
Principal Investigator: Joel Geslevich, MD            
Sub-Investigator: Amir Weiss, MD            
Principal Investigator: Shabtai Romano, MD            
Principal Investigator: Shlomit Goldman, DSc            
Principal Investigator: Eliezer Shalev, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
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
  More Information

Publications of Results:
Study ID Numbers: 3280105, Ministry of Heath:920050038, Genetics committee: 2005-061
Study First Received: August 20, 2006
Last Updated: August 20, 2006
ClinicalTrials.gov Identifier: NCT00367367  
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
embryo transfer
hysteroscopy
curettage
iv-vitro fertilization
molecular markers
endometrial receptivity
endometrial dating

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 16, 2009