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Trial record 20 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases

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ClinicalTrials.gov Identifier: NCT00830401
Recruitment Status : Terminated (Abnormality prevalence revealed to be much lower than expected.)
First Posted : January 27, 2009
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
AZ-VUB
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE January 26, 2009
First Posted Date  ICMJE January 27, 2009
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE June 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
Cumulative implantation rate [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00830401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
  • Cumulative ongoing pregnancy [ Time Frame: One year ]
  • Presence of minor uterine abnormalities [ Time Frame: At hysteroscopy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases
Official Title  ICMJE Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
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.
Detailed Description

Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence.

Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.

Material & methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Minor Intra-uterine Abnormalities
Intervention  ICMJE
  • Procedure: Treatment of predefined abnormality by hysteroscopic surgery
    • 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
  • Drug: Ofloxacinum/Doxycycline
    Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
Study Arms  ICMJE
  • No Intervention: 1
    One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy.
  • Active Comparator: 2
    One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
    Interventions:
    • Procedure: Treatment of predefined abnormality by hysteroscopic surgery
    • Drug: Ofloxacinum/Doxycycline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 26, 2009)
700
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 36 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00830401
Other Study ID Numbers  ICMJE TEAtrial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bart CJM Fauser, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE AZ-VUB
Investigators  ICMJE
Study Chair: Bart CJM Fauser, Prof. dr. UMC Utrecht
Study Chair: Paul Devroey, Prof. dr. AZ-VUB
Study Director: Frank JM Broekmans, Dr. UMC Utrecht
Study Director: Human M Fatemi, Dr. AZ-VUB
Principal Investigator: Jenneke C Kasius UMC Utrecht
PRS Account UMC Utrecht
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP