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

This study has been terminated.
(Abnormality prevalence revealed to be much lower than expected.)
Sponsor:
Collaborator:
AZ-VUB
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00830401
First received: January 26, 2009
Last updated: January 30, 2009
Last verified: January 2009

January 26, 2009
January 30, 2009
June 2007
November 2008   (final data collection date for primary outcome measure)
Cumulative implantation rate [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830401 on ClinicalTrials.gov Archive Site
  • Cumulative ongoing pregnancy [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Presence of minor uterine abnormalities [ Time Frame: At hysteroscopy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases
Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Minor Intra-Uterine Abnormalities
  • 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.
  • 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
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.
 
Terminated
700
March 2009
November 2008   (final data collection date for primary outcome measure)

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
Female
up to 36 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00830401
TEAtrial
No
Prof. dr. CJM Fauser, UMC Utrecht
UMC Utrecht
AZ-VUB
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
UMC Utrecht
January 2009

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