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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Minor Intra-Uterine Abnormalities
 Procedure: Treatment of predefined abnormality by hysteroscopic surgery
Drug: Ofloxacinum/Doxycycline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Cumulative implantation rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 700
Study Start Date: June 2007
Estimated Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   up to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830401

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3500VW
Sponsors and Collaborators
UMC Utrecht
AZ-VUB
Investigators
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
  More Information

No publications provided

Responsible Party: Prof. dr. CJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00830401     History of Changes
Other Study ID Numbers: TEAtrial
Study First Received: January 26, 2009
Last Updated: January 30, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
intra-uterine abnormalities
intracavitary pathology
hysteroscopy
IVF
ICSI
 polyp
myoma
adhesion
septum
endometritis

Additional relevant MeSH terms:
Congenital Abnormalities
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013