NCT01132144

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2014

Completed
Last Updated

February 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

May 26, 2010

Results QC Date

June 18, 2013

Last Update Submit

January 2, 2014

Conditions

Infertility

Keywords

Reproductive TechniquesEmbryo ImplantationEndometriumUltrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Clinical Pregnancy

    3 months

  • Ongoing Pregnancy

    6 months

  • Miscarriage

    9 months

  • Implantation Rate

    3 months

  • Endometrial Thickness

    1 month

  • +3 more secondary outcomes

Study Arms (2)

Endometrial injury group

EXPERIMENTAL

Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.

Procedure: Endometrial injury

Control group

SHAM COMPARATOR

Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.

Procedure: Control group

Interventions

Endometrial injuryPROCEDURE

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.

Endometrial injury group
Control groupPROCEDURE

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

Also known as: Sham procedure
Control group

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who will start assisted reproductive techniques with planned fresh embryo transfer.
  • Age between 18 and 38 years.
  • Written informed consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Setor de Reproducao Humana do HC-FMRP-USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

  • Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.

    PMID: 34110001DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Dr. Wellington P Martins
Organization
University of Sao Paulo
wpmartins@gmail.com
55162231

Study Officials

  • Wellington P Martins, PhD

    Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 17, 2014

Results First Posted

February 17, 2014

Record last verified: 2014-01

Locations

BR(1)