InfertilityPhase 3NCT01132144
Endometrial Injury for Assisted Reproduction
A Phase 3 study testing Endometrial injury in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women who will start assisted reproductive techniques with planned fresh embryo transfer.
- Age between 18 and 38 years.
- Written informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Setor de Reproducao Humana do HC-FMRP-USP
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.
- Conditions
- Infertility
- Being tested
- Endometrial injury, Control group
- Keywords
- Reproductive Techniques, Embryo Implantation, Endometrium, Ultrasonography
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial injuryProcedure or surgery
Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.
Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.
Endometrial injury:
- Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
- Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
- Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping.
Control groupProcedure or surgery
Also called Sham procedure
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury group | Experimental | Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. Receives: Procedure: Endometrial injury |
| Control group | Sham comparator | Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.
Note: All allocated women will be used as denominator when assessing live birth rate.
Measured: 1 year
Secondary outcomes (8)
Clinical Pregnancy
Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.
Note: All allocated women will be considered when assessing clinical pregnancy rate.
Measured: 3 months
Ongoing Pregnancy
At least one fetus with heart beat after 12 weeks of gestational age.
Note: All allocated women will be considered when assessing ongoing pregnancy rate.
Measured: 6 months
Miscarriage
Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).
Note: All allocated women will be considered when assessing miscarriage rate.
Measured: 9 months
Implantation Rate
The number of gestational sacs observed divided by the number of embryos transferred.
Measured: 3 months
Endometrial Thickness
The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
Measured: 1 month
Endometrial Volume
The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
Measured: 1 month
Three-dimensional Doppler Indices From Endometrium (VFI)
Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.
Such indices have no scale.
Measured: 1 month
Procedure Related Pain
Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: "No Pain" = 0 cm and "Very Severe Pain" = 10 cm.
This outcome will be assessed in both groups, just after endometrial injury or sham procedure.
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Stopped after safety analysis because of significant benefit of intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Wellington P Martins, MD, University of Sao Paulo
- Investigators
- Wellington P Martins, PhD, Principal investigator, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132144
- Sponsor's protocol ID
- HCRP10340/09
- Status last verified
- Jan 2014
- First submitted
- 26 May 2010
- Last updated
- 17 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01132144
- Acronym / sponsor ID
- HCRP10340/09
- Conditions
- Infertility
- Keywords
- Reproductive Techniques, Embryo Implantation, Endometrium, Ultrasonography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped after safety analysis because of significant benefit of intervention.
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Posted 17 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury group | Experimental | Procedure: Endometrial injuryEndometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. |
| Control group | Sham comparator | Procedure: Control groupIntroduction of the speculum and wiping of the cervix with gaze for 30 seconds. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who will start assisted reproductive techniques with planned fresh embryo transfer.
- Age between 18 and 38 years.
- Written informed consent.
Key exclusion criteria (1 listed)
- None
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 injuryEvaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full. Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation. Endometrial injury: * Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position. * Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure. * Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping. | Procedure or surgery | Endometrial injury group |
| Control groupAlso: Sham procedureThe investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping. | Procedure or surgery | Control group |
Primary outcome
Live Birth
Time frame: 1 year
The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. Note: All allocated women will be used as denominator when assessing live birth rate.
8 secondary outcomes
Clinical Pregnancy
Time frame: 3 months
Ongoing Pregnancy
Time frame: 6 months
Miscarriage
Time frame: 9 months
Implantation Rate
Time frame: 3 months
Endometrial Thickness
Time frame: 1 month
Endometrial Volume
Time frame: 1 month
Three-dimensional Doppler Indices From Endometrium (VFI)
Time frame: 1 month
Procedure Related Pain
Time frame: Immediately after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Wellington P Martins, PhD principal investigator
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endometrial injury in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
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: stopped early, as of the sponsor's last update on 17 Feb 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 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?
Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Live Birth (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 NCT01132144, 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 17 Feb 2014.