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

Primary Purpose

Minor Intra-uterine Abnormalities

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Treatment of predefined abnormality by hysteroscopic surgery
Ofloxacinum/Doxycycline
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minor Intra-uterine Abnormalities focused on measuring intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion, septum, endometritis

Eligibility Criteria

undefined - 36 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative implantation rate

Secondary Outcome Measures

Cumulative ongoing pregnancy
Presence of minor uterine abnormalities

Full Information

First Posted
January 26, 2009
Last Updated
June 3, 2015
Sponsor
UMC Utrecht
Collaborators
AZ-VUB
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1. Study Identification

Unique Protocol Identification Number
NCT00830401
Brief Title
The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases
Official Title
Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Abnormality prevalence revealed to be much lower than expected.
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
AZ-VUB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minor Intra-uterine Abnormalities
Keywords
intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion, septum, endometritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy.
Arm Title
2
Arm Type
Active Comparator
Arm Description
One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
Intervention Type
Procedure
Intervention Name(s)
Treatment of predefined abnormality by hysteroscopic surgery
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ofloxacinum/Doxycycline
Intervention Description
Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
Primary Outcome Measure Information:
Title
Cumulative implantation rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Cumulative ongoing pregnancy
Time Frame
One year
Title
Presence of minor uterine abnormalities
Time Frame
At hysteroscopy

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart CJM Fauser, Prof. dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Devroey, Prof. dr.
Organizational Affiliation
AZ-VUB
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frank JM Broekmans, Dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Human M Fatemi, Dr.
Organizational Affiliation
AZ-VUB
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jenneke C Kasius
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3500VW
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23499151
Citation
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.
Results Reference
derived

Learn more about this trial

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

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