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

Condition(s) targeted: Minor Intra-uterine Abnormalities

Intervention: Treatment of predefined abnormality by hysteroscopic surgery (Procedure); Ofloxacinum/Doxycycline (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Bart CJM Fauser, Prof. dr., Study Chair, Affiliation: UMC Utrecht
Paul Devroey, Prof. dr., Study Chair, Affiliation: AZ-VUB
Frank JM Broekmans, Dr., Study Director, Affiliation: UMC Utrecht
Human M Fatemi, Dr., Study Director, Affiliation: AZ-VUB
Jenneke C Kasius, Principal Investigator, Affiliation: UMC Utrecht

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.

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

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

Primary outcome: Cumulative implantation rate

Secondary outcome:

Cumulative ongoing pregnancy

Presence of minor uterine abnormalities

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.

Minimum age: N/A. Maximum age: 36 Years. Gender(s): Female.

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

UMC Utrecht, Utrecht 3500VW, Netherlands

Starting date: June 2007
Last updated: June 3, 2015