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Endometrial Curettage Before Embryo Transfer

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ClinicalTrials.gov Identifier: NCT00367367
Recruitment Status : Unknown
Verified August 2006 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : August 22, 2006
Last Update Posted : August 22, 2006
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Procedure: Hysteroscopy and Curettage Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
Study Start Date : December 2005



Primary Outcome Measures :
  1. Implantation rate
  2. Pregnancy rate
  3. Endometrial receptivity


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00367367     History of Changes
Other Study ID Numbers: 3280105
Ministry of Heath:920050038
Genetics committee: 2005-061
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: August 22, 2006
Last Verified: August 2006

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female