InfertilityNCT00367367
Endometrial Curettage Before Embryo Transfer
A study testing Hysteroscopy and Curettage in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hysteroscopy and Curettage
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- In-vitro fertilization candidate
- Normal blood coagulation
Who cannot join
- Anemia (hemoglobin under 10 mg/dl)
- Abnormal maternal karyotype
- Thrombocytopenia under 140,000
- Any contraindication to hysteroscopy or in-vitro fertilization
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Obstetrics and gynecology, HaEmek Medical Center
Afula, 18101
Joel Geslevich, MD
Amir Weiss, MD
About this study
Official title: Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
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.
Read the 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
- 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.
- Conditions
- Infertility
- Being tested
- Hysteroscopy and Curettage
- Keywords
- embryo transfer, hysteroscopy, curettage, iv-vitro fertilization, molecular markers, endometrial receptivity, endometrial dating
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopy and CurettageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Pregnancy rate
Endometrial receptivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Investigators
- Joel Geslevich, MD, Principal investigator, haemek medical centerEliezer Shalev, Study chair, HaEmek Medicak Center and Technion, Israel Institute of TechnologyShlomit Goldman, Study director, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367367
- Sponsor's protocol ID
- 3280105
- Other IDs
- Ministry of Heath:920050038, Genetics committee: 2005-061
- Status last verified
- Aug 2006
- First submitted
- 20 Aug 2006
- Last updated
- 22 Aug 2006
- Results posted
- No
Publications
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.
PubMed 9696242Barash 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.
PubMed 12798877
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer
- ClinicalTrials.gov ID
- NCT00367367
- Acronym / sponsor ID
- 3280105
- Conditions
- Infertility
- Keywords
- embryo transfer, hysteroscopy, curettage, iv-vitro fertilization, molecular markers, endometrial receptivity, endometrial dating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Dec 2005
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent
- In-vitro fertilization candidate
- Normal blood coagulation
Key exclusion criteria (4 listed)
- Anemia (hemoglobin under 10 mg/dl)
- Abnormal maternal karyotype
- Thrombocytopenia under 140,000
- Any contraindication to hysteroscopy or in-vitro fertilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopy and Curettage | Procedure or surgery | – |
Primary outcome
Implantation rate
Pregnancy rate
Endometrial receptivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2006.
- Results publication: PubMed 9696242La 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.
- Results publication: PubMed 12798877Barash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Geslevich, MD principal investigator
haemek medical center
Eliezer Shalev study chair
HaEmek Medicak Center and Technion, Israel Institute of Technology
Shlomit Goldman study director
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy and Curettage in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Weiss, MD (972-4-6494031, weiss_am@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2006.