Repeated Implantation FailuresPhase 2/3NCT01798862
Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
A Phase 2/3 study testing Endometrial injury by hysteroscopy or pipelle sampling and Proceed to COH directly in people with Repeated Implantation Failures, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women only
- Conditions the study is for
- Repeated Implantation Failures
- What is being tested?
- Endometrial injury by hysteroscopy or pipelle sampling and Proceed to COH directly
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- Mar 2013to Jun 2016
- Phase
- Phase 2/3
- 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 25 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Personal history of 2 or more failed IVF/ICSI cycles (RIF)
- Age</= 42 years
- Good response with good quality embryos in previous attempts (>2)
Who cannot join
- Personal history of endometrial tuberculosis/ antituberculous treatment
- Sonographically detected hydrosalpinges
- Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
- Thrombophilia
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Assisted Reproduction Unit
Alexandroupoli, Thrace
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, 12642
About this study
Official title: The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.
Read the detailed description
Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.
- Conditions
- Repeated Implantation Failures
- Being tested
- Endometrial injury by hysteroscopy or pipelle sampling, Proceed to COH directly
- Keywords
- Failed IVF cycles, IVF outcome parameters, endometrial injury, hysteroscopy, pipelle sampling, Repeated implantation failures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial injury by hysteroscopy or pipelle samplingProcedure or surgery
Proceed to COH directlyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury by hysteroscopy or pipelle sapling | Experimental | Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle. Receives: Procedure: Endometrial injury by hysteroscopy or pipelle sampling |
| COH for IVF without hysteroscopy or pipelle sampling | Active comparator | Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied. Receives: Procedure: Proceed to COH directly |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive bHCG rate
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
clinical pregnancy rate
Measured: 2 years
live birth rate
Measured: 2 years
Ectopic pregnancy rate
Measured: 2 years
Miscarriage rate
Measured: 2 years
Ongoing pregnancy rate
Measured: 2 years
Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)
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 posted26 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Repeated Implantation FailuresStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
- Investigators
- Maria Kreatsa, MD/PhD, Principal investigator, National and Kapodistrian University of AthensCharalampos Siristatidis, MD, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798862
- Sponsor's protocol ID
- 121212
- Status last verified
- Jun 2016
- First submitted
- 19 Feb 2013
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.
PubMed 22943664Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
PubMed 20070722Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
PubMed 20607003El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.
PubMed 22885017Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.
PubMed 23063812
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
- ClinicalTrials.gov ID
- NCT01798862
- Acronym / sponsor ID
- 121212
- Conditions
- Repeated Implantation Failures
- Keywords
- Failed IVF cycles, IVF outcome parameters, endometrial injury, hysteroscopy, pipelle sampling, Repeated implantation failures
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Feb 2013 (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.
The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.
Detailed description
Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury by hysteroscopy or pipelle sapling | Experimental | Procedure: Endometrial injury by hysteroscopy or pipelle samplingEndometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle. |
| COH for IVF without hysteroscopy or pipelle sampling | Active comparator | Procedure: Proceed to COH directlyProcedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied. |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Personal history of 2 or more failed IVF/ICSI cycles (RIF)
- Age</= 42 years
- Good response with good quality embryos in previous attempts (>2)
Key exclusion criteria (4 listed)
- Personal history of endometrial tuberculosis/ antituberculous treatment
- Sonographically detected hydrosalpinges
- Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
- Thrombophilia
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 injury by hysteroscopy or pipelle sampling | Procedure or surgery | Endometrial injury by hysteroscopy or pipelle sapling |
| Proceed to COH directly | Procedure or surgery | COH for IVF without hysteroscopy or pipelle sampling |
Primary outcome
positive bHCG rate
Time frame: through study completion, an average of 2 years
6 secondary outcomes
clinical pregnancy rate
Time frame: 2 years
live birth rate
Time frame: 2 years
Ectopic pregnancy rate
Time frame: 2 years
Miscarriage rate
Time frame: 2 years
Ongoing pregnancy rate
Time frame: 2 years
Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)
Time frame: 2 years
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 10 Jun 2016.
- Background: PubMed 22943664Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.
- Results publication: PubMed 20070722Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
- Results publication: PubMed 20607003Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
- Results publication: PubMed 22885017El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.
- Results publication: PubMed 23063812Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.
- Individual participant dataSharing planned: Yes
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.
Maria Kreatsa, MD/PhD principal investigator
National and Kapodistrian University of Athens
Charalampos Siristatidis, MD, PhD principal investigator
National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Endometrial injury by hysteroscopy or pipelle sampling and Proceed to COH directly in people with Repeated Implantation Failures, run by National and Kapodistrian University of Athens at 2 sites in Greece.
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: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
positive bHCG rate (time frame: through study completion, an average of 2 years). 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 NCT01798862, which also lists 5 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 10 Jun 2016.