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.

Study Overview

• Status: Terminated
• Conditions: Minor Intra-uterine Abnormalities
• Intervention / Treatment: Procedure: Treatment of predefined abnormality by hysteroscopic surgery; Drug: Ofloxacinum/Doxycycline

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: Interventional
• Enrollment (Actual): 700
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3500VW
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 36 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative implantation rate	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative ongoing pregnancy	One year
Presence of minor uterine abnormalities	At hysteroscopy

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (ESTIMATE): January 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: hysteroscopy; IVF; ICSI; polyp; myoma; intracavitary pathology; adhesion; endometritis; septum; intra-uterine abnormalities
• Additional Relevant MeSH Terms: Congenital Abnormalities; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: TEAtrial