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Stopped after safety analysis because of significant benefit of intervention.
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| Name | Class |
|---|---|
| Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. |
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The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial injury group | Experimental | Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. |
|
| Control group | Sham Comparator | Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial injury | Procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wellington P Martins, PhD | Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Setor de Reproducao Humana do HC-FMRP-USP | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34110001 | Derived | 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. |
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All women that fulfilled eligibility criteria were invited to participate. Those who agreed were included. No women was excluded.
The recruitment occurred from July 2010 to March 2012 in the fertility clinic of an university hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometrial Injury Group | Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds. |
| FG001 | Control Group | Introduction of the speculum and wiping of the cervix with gaze for 30 seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endometrial Injury Group | Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All women enrolled. | Posted | Number | participants | 1 year |
|
1 year
Major fetal malformation. The occurrence of major fetal malformation detected at birth was assessed by phone interview with the parents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endometrial Injury Group | Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wellington P Martins | University of Sao Paulo | 55162231 | wpmartins@gmail.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| OTHER_GOV |
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|
| Control group | Procedure | The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping. |
|
|
| 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. |
| 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. | 9 months |
| Implantation Rate | The number of gestational sacs observed divided by the number of embryos transferred. | 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. | 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. | 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. | 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. | Immediately after procedure |
| BG001 | Control Group | Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. |
|
|
| Secondary | 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. | All women enrolled. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | 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. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | 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. | The number of clinical pregnancies was used as denominator, since miscarriage is a harm that can only happen in pregnant women. | Posted | Number | Clinical pregnancies | 9 months |
|
|
|
| Secondary | Implantation Rate | The number of gestational sacs observed divided by the number of embryos transferred. | Not Posted | 3 months |
| Secondary | 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. | Women that achieved at least one follicle >17mm during ovarian stimulation. | Posted | Mean | Standard Deviation | mm | 1 month |
|
|
|
| Secondary | 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. | Women that achieved at least one follicle >17mm during ovarian stimulation. | Posted | Mean | Standard Deviation | cm³ | 1 month |
|
|
|
| Secondary | 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. | Women that achieved at least one follicle >17mm during ovarian stimulation. | Posted | Mean | Standard Deviation | index | 1 month |
|
|
|
| Secondary | 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. | All women enrolled. | Posted | Mean | Standard Deviation | cm | Immediately after procedure |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Control Group | Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. | 0 | 79 | 0 | 79 |
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| D008722 | Methods |