InfertilityNCT00796341
Endometrial Injury and IVF-ET Outcome
A study testing PIPELLE ENDOMETRIAL SAMPLING in people with Infertility, run by Bangalore Assisted Conception Centre at 1 site in India.
Trial summary
Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created… Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- PIPELLE ENDOMETRIAL SAMPLING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2007to Sep 2008
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Previous failed In-vitro fertilization embryo transfer cycle
- Patients who are good responders and have good quality embryos in the previous attempts
- Age of patients upto 37yrs
Who cannot join
- Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
- Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
- Those with sonographically detected hydrosalpinx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Endometrial Injury in the Non-Transfer Cycle Improve the IVF-ET Outcome in the Subsequent Cycle in Patients With Previous Failed IVF Cycles: A Randomized Control Trial
Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.
Read the detailed description
Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.
Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.
Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.
SAMPLE SIZE: 100 PATIENTS (50 in each group).
- Conditions
- Infertility
- Being tested
- PIPELLE ENDOMETRIAL SAMPLING
- Keywords
- invitro-fertilization ,embryo transfer,endometrial injury
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPELLE ENDOMETRIAL SAMPLINGProcedure or surgery
Also called Endometrial sampling
Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: PIPELLE ENDOMETRIAL SAMPLING |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
Measured: 9 MONTHS
Secondary outcomes (1)
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
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
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangalore Assisted Conception Centre
- Sponsor type
- University, hospital or other
- Investigators
- SACHIN A NARVEKAR, MD, Principal investigator, Bangalore Assisted Conception Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796341
- Sponsor's protocol ID
- endometrial injury study
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 2 Dec 2008
- 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 12798877Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
PubMed 34110001
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Endometrial Injury in the Non-Transfer Cycle Improve the IVF-ET Outcome in the Subsequent Cycle in Patients With Previous Failed IVF Cycles: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00796341
- Acronym / sponsor ID
- endometrial injury study
- Conditions
- Infertility
- Keywords
- invitro-fertilization ,embryo transfer,endometrial injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bangalore Assisted Conception CentreUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Nov 2008 (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.
Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.
Detailed description
Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.
Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.
Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.
SAMPLE SIZE: 100 PATIENTS (50 in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PIPELLE ENDOMETRIAL SAMPLING |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Previous failed In-vitro fertilization embryo transfer cycle
- Patients who are good responders and have good quality embryos in the previous attempts
- Age of patients upto 37yrs
Key exclusion criteria (3 listed)
- Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
- Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
- Those with sonographically detected hydrosalpinx
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 |
|---|---|---|
| PIPELLE ENDOMETRIAL SAMPLINGAlso: Endometrial samplingPipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF. | Procedure or surgery | 1 |
Primary outcome
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
Time frame: 9 MONTHS
1 secondary outcome
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
Time frame: 9 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2008.
- 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.
- Derived from this study: PubMed 34110001Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
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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.
SACHIN A NARVEKAR, MD principal investigator
Bangalore Assisted Conception Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIPELLE ENDOMETRIAL SAMPLING in people with Infertility, run by Bangalore Assisted Conception Centre at 1 site in India.
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 3 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: finished, as of the sponsor's last update on 2 Dec 2008. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (time frame: 9 MONTHS). 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 NCT00796341, 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 2 Dec 2008.