Endometrial Curettage Before Embryo Transfer

Infertility Clinical Trial

Official title:

Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00367367
• Other study ID #: 3280105
• Secondary ID: Ministry of Heat
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2006
• Last updated: August 20, 2006
• Start date: December 2005

Study information

• Verified date: August 2006
• Source: HaEmek Medical Center, Israel
• Contact: Amir Weiss, MD
• Phone: 972-4-6494031
• Email: weiss_am[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Hysteroscopy and Curettage

Locations

Country	Name	City	State
Israel	Department of Obstetrics and gynecology, HaEmek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate
Primary	Pregnancy rate
Primary	Endometrial receptivity