Endometrial Injury for Assisted Reproduction

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01132144
• Other study ID #: HCRP10340/09
• Status: Terminated
• Phase: Phase 3
• First received: May 26, 2010
• Last updated: January 2, 2014
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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. 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.
• Control group
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.

Locations

Country	Name	City	State
Brazil	Setor de Reproducao Humana do HC-FMRP-USP	Ribeirao Preto	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., FAEPA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year	Yes
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.	3 months	Yes
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.	6 months	Yes
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.	9 months	Yes
Secondary	Implantation Rate	The number of gestational sacs observed divided by the number of embryos transferred.	3 months	Yes
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.	1 month	No
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.	1 month	No
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.	1 month	No
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.	Immediately after procedure	No