Endometrial Curettage Before Embryo Transfer

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Unknown status

CT.gov ID

NCT00367367

Collaborator

Technion, Israel Institute of Technology (Other)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: Hysteroscopy and Curettage	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Implantation rate []
Pregnancy rate []
Endometrial receptivity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and gynecology, HaEmek Medical Center	Afula		Israel	18101

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