Endometrial Curettage Before Embryo Transfer

NCT ID: NCT00367367

Last Updated: 2006-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Infertility

Keywords

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embryo transfer hysteroscopy curettage iv-vitro fertilization molecular markers endometrial receptivity endometrial dating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hysteroscopy and Curettage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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Joel Geslevich, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Eliezer Shalev

Role: STUDY_CHAIR

HaEmek Medicak Center and Technion, Israel Institute of Technology

Shlomit Goldman

Role: STUDY_DIRECTOR

haemek medical center

Locations

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Department of Obstetrics and gynecology, HaEmek Medical Center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Amir Weiss, MD

Role: CONTACT

Phone: 972-4-6494031

Email: [email protected]

Joel Geslevich, MD

Role: CONTACT

Phone: 972-4-6495488

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 9696242 (View on PubMed)

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.

Reference Type RESULT
PMID: 12798877 (View on PubMed)

Other Identifiers

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Ministry of Heath:920050038

Identifier Type: -

Identifier Source: secondary_id

Genetics committee: 2005-061

Identifier Type: -

Identifier Source: secondary_id

3280105

Identifier Type: -

Identifier Source: org_study_id