Endometrial Injury for Assisted Reproduction

Phase 3

Terminated

• Conditions: Infertility
• Interventions: Procedure: Control group; Procedure: Endometrial injury

• Registration Number: NCT01132144
• Lead Sponsor: University of Sao Paulo

Brief Summary

The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Study Start: 2010-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-06-18
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Results First Posted: 2014-02-17
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
Endometrial injury group	Endometrial injury	Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
Live Birth	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.

Secondary Outcome Measures

Name	Time	Method
Implantation Rate	3 months	The number of gestational sacs observed divided by the number of embryos transferred.
Endometrial Thickness	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	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.
Clinical Pregnancy	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.
Three-dimensional Doppler Indices From Endometrium (VFI)	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	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.
Ongoing Pregnancy	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	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.

Trial Locations

Locations (1)

Setor de Reproducao Humana do HC-FMRP-USP; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil