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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Minor Intra-uterine Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type ACTIVE_COMPARATOR

Treatment of predefined abnormality by hysteroscopic surgery

Intervention Type PROCEDURE

* 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

Ofloxacinum/Doxycycline

Intervention Type DRUG

Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.

Interventions

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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

Intervention Type PROCEDURE

Ofloxacinum/Doxycycline

Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes