Implantation RatePhase 2NCT00846183
Effect of Local Injury on Implantation
A Phase 2 study testing local injury in people with Implantation Rate, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
Trial summary
Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Implantation Rate
- What is being tested?
- local injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteIran
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 2
- 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 Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age < 35
- First IVF cycle
- Long protocol should be used for stimulation
Who cannot join
- Day 3 FSH > 10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.
Read the detailed description
Low implantation rate is still a major concern in ART cycles. It has been reported that local injury to endometrium may improve endometrial receptivity and implantation rate. A total of 120 patients in first IVF cycles, who are stimulated with long protocol, are randomly divided into two groups. In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed and in the other group no interventions are done. After fresh embryo transfers, implantation and clinical pregnancy rates are compared between two groups.
- Conditions
- Implantation Rate
- Being tested
- local injury
- Keywords
- local injury, implantation rate, endometrial receptivity, IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local injuryProcedure or surgery
Also called it does not have other name
In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed
| Study group | Role | What they receive |
|---|---|---|
| local ingury | Active comparator | In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed. Receives: Procedure: local injury |
| control | No intervention | in 60 patients routine IVF are performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
Measured: 4 weeks
Secondary outcomes (1)
clinical pregnancy rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionJun 2009
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 Implantation RateStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yazd Research & Clinical Center for Infertility
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, homa oskouian, Yazd Research & Clinical Center for Infertility
- Investigators
- homa oskouian, M.D., Principal investigator, Research and clinical center for infertilityMohamad ali karimzade, MD, Principal investigator, Research and clinical center for infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846183
- Sponsor's protocol ID
- local injury111
- Status last verified
- Dec 2013
- First submitted
- 17 Feb 2009
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lensen 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 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
- ClinicalTrials.gov ID
- NCT00846183
- Acronym / sponsor ID
- local injury111
- Conditions
- Implantation Rate
- Keywords
- local injury, implantation rate, endometrial receptivity, IVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Yazd Research & Clinical Center for InfertilityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Feb 2009 (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.
Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.
Detailed description
Low implantation rate is still a major concern in ART cycles. It has been reported that local injury to endometrium may improve endometrial receptivity and implantation rate. A total of 120 patients in first IVF cycles, who are stimulated with long protocol, are randomly divided into two groups. In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed and in the other group no interventions are done. After fresh embryo transfers, implantation and clinical pregnancy rates are compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local ingury | Active comparator | Procedure: local injuryIn one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed. |
| control | No intervention | –in 60 patients routine IVF are performed |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age < 35
- First IVF cycle
- Long protocol should be used for stimulation
Key exclusion criteria (1 listed)
- Day 3 FSH > 10
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 |
|---|---|---|
| local injuryAlso: it does not have other nameIn one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed | Procedure or surgery | local ingury |
Primary outcome
implantation rate
Time frame: 4 weeks
1 secondary outcome
clinical pregnancy rate
Time frame: 4 weeks
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 23 Dec 2013.
- 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.
homa oskouian, M.D. principal investigator
Research and clinical center for infertility
Mohamad ali karimzade, MD principal investigator
Research and clinical center for infertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing local injury in people with Implantation Rate, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
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 1 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 23 Dec 2013. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
implantation rate (time frame: 4 weeks). 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 NCT00846183, 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 23 Dec 2013.