InfertilityNCT01111799
Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?
A study testing endometrial biopsy and natural cycle + IUI + endometrial biopsy in people with Infertility and Implantation Failure, run by Meir Medical Center at 1 site in Israel.
Trial summary
It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Implantation Failure
- What is being tested?
- endometrial biopsy and natural cycle + IUI + endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Oct 2012
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-38.
- infertility.
- patients undergoing IUI treatment.
- at least one failed IUI cycle.
Who cannot join
- indication for IVF treatment.
- Known Pelvic inflammatory disease(PID).
Trial locations and contacts
1 site in 1 country.
Leila Aliger, MD contact
Israel1 site, 1 recruiting
- Recruiting
Remez women medical center
Rehovot
Yuval Or, MD, +97289445150, yuval_o@clalit.org.il
Ayelet Mokasey, +97589445150, ayeletmo@clalit.org.il
About this study
Official title: Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment
It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).
Read the detailed description
In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.
- Conditions
- Infertility, Implantation Failure
- Being tested
- endometrial biopsy, natural cycle + IUI + endometrial biopsy
- Keywords
- endometrial biopsy, implantation, uterine receptivity, infertility, controled ovarian hyperstimulation, intra uterine insemination
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
endometrial biopsyProcedure or surgery
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
natural cycle + IUI + endometrial biopsyProcedure or surgery
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate + IUI + endometrial biopsy | Experimental | Clomiphene citrate + IUI + endometrial biopsy Receives: Procedure: endometrial biopsy |
| Clomiphene citrate + IUI | No intervention | Not described |
| gonadotrophines + IUI + endometrial biopsy | Experimental | two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. Receives: Procedure: endometrial biopsy |
| gonadotrophines + IUI | No intervention | Not described |
| natural cycle + IUI + endometrail biopsy | Experimental | two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. Receives: Procedure: natural cycle + IUI + endometrial biopsy |
| natural cycle + IUI | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy rate
Measured: 1 year
Secondary outcomes (1)
Live birth
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuval Or, MD, Study director, Clalit health service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111799
- Sponsor's protocol ID
- 004608K
- Status last verified
- Mar 2012
- First submitted
- 21 Apr 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12798877
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment
- ClinicalTrials.gov ID
- NCT01111799
- Acronym / sponsor ID
- 004608K
- Conditions
- Infertility, Implantation Failure
- Keywords
- endometrial biopsy, implantation, uterine receptivity, infertility, controled ovarian hyperstimulation, intra uterine insemination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 28 Apr 2010 (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.
It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).
Detailed description
In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate + IUI + endometrial biopsy | Experimental | Procedure: endometrial biopsyClomiphene citrate + IUI + endometrial biopsy |
| Clomiphene citrate + IUI | No intervention | – |
| gonadotrophines + IUI + endometrial biopsy | Experimental | Procedure: endometrial biopsytwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. |
| gonadotrophines + IUI | No intervention | – |
| natural cycle + IUI + endometrail biopsy | Experimental | Procedure: natural cycle + IUI + endometrial biopsytwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. |
| natural cycle + IUI | No intervention | – |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-38.
- infertility.
- patients undergoing IUI treatment.
- at least one failed IUI cycle.
Key exclusion criteria (2 listed)
- indication for IVF treatment.
- Known Pelvic inflammatory disease(PID).
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 |
|---|---|---|
| endometrial biopsytwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. | Procedure or surgery | Clomiphene citrate + IUI + endometrial biopsy |
| endometrial biopsytwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. | Procedure or surgery | gonadotrophines + IUI + endometrial biopsy |
| natural cycle + IUI + endometrial biopsytwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. | Procedure or surgery | natural cycle + IUI + endometrail biopsy |
Primary outcome
Clinical Pregnancy rate
Time frame: 1 year
1 secondary outcome
Live birth
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
- Background: 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.
Leila Aliger, MD contact
Yuval Or, MD study director
Clalit health service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy and natural cycle + IUI + endometrial biopsy in people with Infertility and Implantation Failure, run by Meir Medical Center 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 4 inclusion and 2 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 16 Mar 2012. 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 Yuval Or, MD (+97289445150, yuval_o@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy rate (time frame: 1 year). 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 NCT01111799, which also lists 1 linked publication.
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 16 Mar 2012.