NCT00830401

Brief Summary

This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

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

Study Start

First participant enrolled

June 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

January 26, 2009

Last Update Submit

June 3, 2015

Conditions

Minor Intra-uterine Abnormalities

Keywords

intra-uterine abnormalitiesintracavitary pathologyhysteroscopyIVFICSIpolypmyomaadhesionseptumendometritis

Outcome Measures

Primary Outcomes (1)

  • Cumulative implantation rate

    One year

Secondary Outcomes (2)

  • Cumulative ongoing pregnancy

    One year

  • Presence of minor uterine abnormalities

    At hysteroscopy

Study Arms (2)

1

NO INTERVENTION

One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy.

2

ACTIVE COMPARATOR

One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.

Procedure: Treatment of predefined abnormality by hysteroscopic surgeryDrug: Ofloxacinum/Doxycycline

Interventions

Treatment of predefined abnormality by hysteroscopic surgeryPROCEDURE

* Polyp resection with Hysteroscopic scissors or Versapoint * Resection of myoma with Resectoscope Storz or Versapoint * Septum resection with Resectoscope Storz or Versapoint * Resection of adhesions with Hysteroscopic scissors or Versapoint

2
Ofloxacinum/DoxycyclineDRUG

Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.

2

Eligibility Criteria

AgeUp to 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Normal Transvaginal Ultrasound
  • No prior hysteroscopy
  • Regular menstrual cycle
  • Single embryo transfer
  • BMI between 18 and 29
  • Presence of both ovaries
  • Primary or secondary infertility
  • Women indicated for a first IVF/ICSI cycle

You may not qualify if:

  • Recurrent miscarriage
  • Prior hysteroscopic treatments
  • Endometriosis \> AFS Stage II
  • Meno-metrorrhagia (defined as any intermenstrual loss of blood)
  • Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
  • Hydrosalpinx
  • FSH/LH \> 12IU/L on day 3
  • Polyps taking more than 50% of the cavity
  • Severe adhesions \> grade II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3500VW, Netherlands

Location

Related Publications (1)

  • Smit JG, Kasius JC, Eijkemans MJ, Veersema S, Fatemi HM, Santbrink van EJ, Campo R, Broekmans FJ. The international agreement study on the diagnosis of the septate uterus at office hysteroscopy in infertile patients. Fertil Steril. 2013 Jun;99(7):2108-13.e2. doi: 10.1016/j.fertnstert.2013.02.027. Epub 2013 Mar 13.

    PMID: 23499151DERIVED

MeSH Terms

Conditions

PolypsMyomaTissue AdhesionsEndometritis

Interventions

OfloxacinDoxycycline

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsCicatrixFibrosisPathologic ProcessesPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Bart CJM Fauser, Prof. dr.

    UMC Utrecht

    STUDY CHAIR

  • Paul Devroey, Prof. dr.

    AZ-VUB

    STUDY CHAIR

  • Frank JM Broekmans, Dr.

    UMC Utrecht

    STUDY DIRECTOR

  • Human M Fatemi, Dr.

    AZ-VUB

    STUDY DIRECTOR

  • Jenneke C Kasius

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

June 1, 2007

Primary Completion

November 1, 2008

Study Completion

March 1, 2009

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

NL(1)