Endometrial Curettage Before Embryo Transfer | NCT00367367

Studies
Endometrial Curettage Before Embryo Transfer

NCT00367367

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Aug 22, 2006Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Hysteroscopy and Curettage

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 20, 2006

First Submission Date that Met QC Criteria

Aug 20, 2006

First Posted Date

Aug 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2006

Last Update Posted Date

Aug 22, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Name	Class
Technion, Israel Institute of Technology	OTHER

Description Module

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
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
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Name	Type	Description	Arm Group Labels	Other Names
Hysteroscopy and Curettage	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implantation rate
Pregnancy rate
Endometrial receptivity

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amir Weiss, MD	Contact	972-4-6494031		weiss_am@clalit.org.il
Joel Geslevich, MD	Contact	972-4-6495488		yoel_g@clalit.org.il

Overall Officials

Name	Affiliation	Role
Joel Geslevich, MD	haemek medical center	Principal Investigator
Eliezer Shalev	HaEmek Medicak Center and Technion, Israel Institute of Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and gynecology, HaEmek Medical Center	Recruiting	Afula		18101	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9696242	Result	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.
12798877	Result	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

ID	Type	Description	Link
Ministry of Heath:920050038
Genetics committee: 2005-061