The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
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.
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
Setor de Reproducao Humana do HC-FMRP-USP
Ribeirão Preto, São Paulo, Brazil
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
Implantation Rate
The number of gestational sacs observed divided by the number of embryos transferred.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after procedure