Endometrial Curettage Before Embryo Transfer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00367367
First received: August 20, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00367367     History of Changes
Other Study ID Numbers: 3280105, Ministry of Heath:920050038, Genetics committee: 2005-061
Study First Received: August 20, 2006
Last Updated: August 20, 2006
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

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

ClinicalTrials.gov processed this record on October 19, 2014