Endometrial Curettage Before Embryo Transfer
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscopy and Curettage
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring embryo transfer, hysteroscopy, curettage, iv-vitro fertilization, molecular markers, endometrial receptivity, endometrial dating
Eligibility 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
Sites / Locations
- Department of Obstetrics and gynecology, HaEmek Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Implantation rate
Pregnancy rate
Endometrial receptivity
Secondary Outcome Measures
Full Information
NCT ID
NCT00367367
First Posted
August 20, 2006
Last Updated
August 20, 2006
Sponsor
HaEmek Medical Center, Israel
Collaborators
Technion, Israel Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT00367367
Brief Title
Endometrial Curettage Before Embryo Transfer
Official Title
Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
Collaborators
Technion, Israel Institute of Technology
4. Oversight
5. Study Description
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.
Detailed Description
It has been suggested that local injury to the endometrium doubles the rate of implantation and successful pregnancies in IVF patients.
Purpose
To determine whether performing curettage the month prior to embryo transfer (ET) increases the chance of embryo implantation.
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:
Informed consent obtained from prospective candidates.
Participants randomly divided to three groups
Control group
Hysteroscopy and curettage performed on days 15-17 of menstrual cycle
Hysteroscopy and curettage performed on days 19-22 of menstrual cycle
After the following menses an IVF, IVF-ICSI, or frozen embryo cycle is performed according to the unit's standard protocols.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
embryo transfer, hysteroscopy, curettage, iv-vitro fertilization, molecular markers, endometrial receptivity, endometrial dating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy and Curettage
Primary Outcome Measure Information:
Title
Implantation rate
Title
Pregnancy rate
Title
Endometrial receptivity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Weiss, MD
Phone
972-4-6494031
Email
weiss_am@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Geslevich, MD
Phone
972-4-6495488
Email
yoel_g@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Geslevich, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliezer Shalev
Organizational Affiliation
HaEmek Medicak Center and Technion, Israel Institute of Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shlomit Goldman
Organizational Affiliation
haemek medical center
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and gynecology, HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Geslevich, MD
First Name & Middle Initial & Last Name & Degree
Amir Weiss, MD
First Name & Middle Initial & Last Name & Degree
Shabtai Romano, MD
First Name & Middle Initial & Last Name & Degree
Shlomit Goldman, DSc
First Name & Middle Initial & Last Name & Degree
Eliezer Shalev, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
9696242
Citation
La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998 Aug;70(2):378-80. doi: 10.1016/s0015-0282(98)00147-2.
Results Reference
result
PubMed Identifier
12798877
Citation
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Results Reference
result
Learn more about this trial
Endometrial Curettage Before Embryo Transfer
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