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

Minor Intra-uterine Abnormalities Clinical Trial

Official title:

Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00830401
• Other study ID #: TEAtrial
• Status: Terminated
• Phase: Phase 2
• First received: January 26, 2009
• Last updated: June 3, 2015
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 700
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 36 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Minor Intra-uterine Abnormalities
• Urogenital Abnormalities

Intervention

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.

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	AZ-VUB

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative implantation rate		One year	No
Secondary	Cumulative ongoing pregnancy		One year	No
Secondary	Presence of minor uterine abnormalities		At hysteroscopy	No