SubfertilityNCT02093442
Endometrial Scratching for Cryopreserved Embryo Transfer
A study testing Endometrial injury in people with Subfertility, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Endometrial injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Jun 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18
- At least one cryopreserved embryo
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Setor de Reprodução Humana - FMRP-USP
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Endometrial Scratching for Cryopreserved Embryo Transfer: a Randomized Controlled Trial
Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. However, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.
- Conditions
- Subfertility
- Being tested
- 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.
Endometrial injuryProcedure or surgery
Also called Endometrial scratching
Endometrial biopsy using a pipelle de Cornier
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury | Experimental | Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. Receives: Procedure: Endometrial injury |
| Control | No intervention | Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. |
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.
Measured: 10 months
Secondary outcomes (2)
Clinical pregnancy
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Note: Multiple gestational sacs are counted as one clinical pregnancy.
Measured: 3 months
Miscarriage
The spontaneous loss of a clinical pregnancy
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: The main investigators are no longer working at the center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington P Martins, MD, University of Sao Paulo
- Investigators
- Wellington P Martins, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093442
- Sponsor's protocol ID
- CAAE:03292412.0.0000.5440
- Status last verified
- May 2018
- First submitted
- 18 Mar 2014
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Scratching for Cryopreserved Embryo Transfer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02093442
- Acronym / sponsor ID
- CAAE:03292412.0.0000.5440
- Conditions
- Subfertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The main investigators are no longer working at the center.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Mar 2014 (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.
Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. However, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury | Experimental | Procedure: Endometrial injuryWomen allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. |
| Control | No intervention | –Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age > 18
- At least one cryopreserved embryo
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 injuryAlso: Endometrial scratchingEndometrial biopsy using a pipelle de Cornier | Procedure or surgery | Endometrial injury |
Primary outcome
Live birth
Time frame: 10 months
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.
2 secondary outcomes
Clinical pregnancy
Time frame: 3 months
Miscarriage
Time frame: 5 months
Results and safety
The study was stopped early (reason given: The main investigators are no longer working at the center.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
Wellington P Martins, Ph.D. principal investigator
University of Sao Paulo
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 injury in people with Subfertility, 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 2 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 14 May 2018. 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. 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 was stopped early (reason given: The main investigators are no longer working at the center.). Results are not available in the source record.
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: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.