Endometrial Injury for Assisted Reproduction
|Infertility||Procedure: Endometrial injury Procedure: Control group||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial|
- 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.
- Clinical Pregnancy [ Time Frame: 3 months ]
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.
- Ongoing Pregnancy [ Time Frame: 6 months ]
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.
- Miscarriage [ Time Frame: 9 months ]
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.
- Implantation Rate [ Time Frame: 3 months ]The number of gestational sacs observed divided by the number of embryos transferred.
- Endometrial Thickness [ Time Frame: 1 month ]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.
- Endometrial Volume [ Time Frame: 1 month ]The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
- Three-dimensional Doppler Indices From Endometrium (VFI) [ Time Frame: 1 month ]
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.
- Procedure Related Pain [ Time Frame: Immediately after procedure ]
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.
|Study Start Date:||June 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Endometrial injury group
Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
Procedure: Endometrial injury
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.
Sham Comparator: Control group
Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
Procedure: Control group
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
Other Name: Sham procedure
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132144
|Setor de Reproducao Humana do HC-FMRP-USP|
|Ribeirao Preto, Sao Paulo, Brazil, 14049-900|
|Principal Investigator:||Wellington P Martins, PhD||Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo|