NCT01743391

Brief Summary

By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

December 2, 2012

Last Update Submit

March 14, 2022

Conditions

SubfertilityInfertility

Keywords

IVF treatmentOffice-hysteroscopyEndometrial biopsy

Outcome Measures

Primary Outcomes (1)

  • pregnancy rates

    Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.

    individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.

Study Arms (2)

Control

NO INTERVENTION

Standard treatment

Intervention

EXPERIMENTAL

Office-hysteroscopy with endometrial biopsy before standard treatment

Procedure: Office-hysteroscopy with biopsy

Interventions

Office-hysteroscopy with biopsyPROCEDURE
Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women submitted to IVF or ISCI treatment
  • Age \> 18 years
  • Women able to read, speak and understand Danish
  • Written consent

You may not qualify if:

  • Intrauterine abnormalities
  • Infection
  • BMI \> 35
  • Known intrauterine cause to the infertile condition
  • Abuse of alcohol or drugs
  • Untreated medical condition
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital, Department of Gynecology and Obstetrics

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Berntsen S, Hare KJ, Lossl K, Bogstad J, Palmo J, Praetorius L, Zedeler A, Pinborg A. Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:112-117. doi: 10.1016/j.ejogrb.2020.06.034. Epub 2020 Jun 17.

    PMID: 32593936DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 6, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

DK(1)