Endometrial Injury for Assisted Reproduction

Study Overview
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Brief Summary
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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.

Official Title
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Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Endometrial injury
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who will start assisted reproductive techniques with planned fresh embryo transfer. Age between 18 and 38 years. Written informed consent. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial injury group<br>Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. | Procedure: Endometrial injury<br>* 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.<br>|
| Sham Comparator: Control group<br>Introduction of the speculum and wiping of the cervix with gaze for 30 seconds. | Procedure: Control group<br>* The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.<br>* Other names: Sham procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reproductive Techniques, Embryo Implantation, Endometrium, Ultrasonography