Clinical trial NCT00830401: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Minor Intra-uterine Abnormalities
Keywords: intra-uterine abnormalities
intracavitary pathology
hysteroscopy
IVF
ICSI
polyp
myoma
adhesion
septum
endometritis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: AZ-VUB
First posted: 2009-01-27
Enrollment: 700
Sex: FEMALE
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative implantation rate
timeFrame: One year
Secondary outcomes:
measure: Cumulative ongoing pregnancy
timeFrame: One year
measure: Presence of minor uterine abnormalities
timeFrame: At hysteroscopy
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Bart CJM Fauser, Prof. dr.
role: STUDY_CHAIR
affiliation: AZ-VUB
name: Paul Devroey, Prof. dr.
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Frank JM Broekmans, Dr.
role: STUDY_DIRECTOR
affiliation: AZ-VUB
name: Human M Fatemi, Dr.
role: STUDY_DIRECTOR
affiliation: UMC Utrecht
name: Jenneke C Kasius
role: PRINCIPAL_INVESTIGATOR
References:
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.