Clinical trial NCT00367367: Endometrial Curettage Before Embryo Transfer
Official title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: embryo transfer
hysteroscopy
curettage
iv-vitro fertilization
molecular markers
endometrial receptivity
endometrial dating
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2006-08-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Implantation rate
measure: Pregnancy rate
measure: Endometrial receptivity
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Department of Obstetrics and gynecology, HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: Joel Geslevich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HaEmek Medicak Center and Technion, Israel Institute of Technology
name: Eliezer Shalev
role: STUDY_CHAIR
affiliation: haemek medical center
name: Shlomit Goldman
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0015-0282(98)00147-2.
citation: 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.