Viewing Study NCT00367367


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Study NCT ID: NCT00367367
Status: UNKNOWN
Last Update Posted: 2006-08-22
First Post: 2006-08-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Endometrial Curettage Before Embryo Transfer
Sponsor: HaEmek Medical Center, Israel
Organization:

Study Overview

Official Title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
Status: UNKNOWN
Status Verified Date: 2006-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
Ministry of Heath:920050038 None None View
Genetics committee: 2005-061 None None View