Endometrial Curettage Before Embryo Transfer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility |
Procedure: Hysteroscopy and Curettage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer |
- Implantation rate
- Pregnancy rate
- Endometrial receptivity
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2005 |
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
- Control group
- Hysteroscopy and curettage performed on days 15-17 of menstrual cycle
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Amir Weiss, MD | 972-4-6494031 | weiss_am@clalit.org.il |
| Contact: Joel Geslevich, MD | 972-4-6495488 | yoel_g@clalit.org.il |
| Israel | |
| Department of Obstetrics and gynecology, HaEmek Medical Center | Recruiting |
| Afula, Israel, 18101 | |
| Principal Investigator: Joel Geslevich, MD | |
| Sub-Investigator: Amir Weiss, MD | |
| Principal Investigator: Shabtai Romano, MD | |
| Principal Investigator: Shlomit Goldman, DSc | |
| Principal Investigator: Eliezer Shalev, MD | |
| Principal Investigator: | Joel Geslevich, MD | HaEmek Medical Center |
| Study Chair: | Eliezer Shalev | HaEmek Medicak Center and Technion, Israel Institute of Technology |
| Study Director: | Shlomit Goldman | HaEmek Medical Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00367367 History of Changes |
| Other Study ID Numbers: | 3280105, Ministry of Heath:920050038, Genetics committee: 2005-061 |
| Study First Received: | August 20, 2006 |
| Last Updated: | August 20, 2006 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by HaEmek Medical Center, Israel:
|
embryo transfer hysteroscopy curettage iv-vitro fertilization |
molecular markers endometrial receptivity endometrial dating |
Additional relevant MeSH terms:
|
Infertility Adenoma Genital Diseases, Male Genital Diseases, Female |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013