SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle

Phase 4

Completed

• Conditions: Intrauterine Abnormalities in Infertility
• Interventions: Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))

• Registration Number: NCT01242852
• Lead Sponsor: UMC Utrecht

Brief Summary

BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI.

OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment.

STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.

INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated.

PRIMARY OUTCOME MEASURE:

Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

SECONDARY OUTCOME MEASURE:

* Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

* Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

* Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment

* Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure

* Prevalence of unexpected intrauterine abnormalities

* Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Study Start: 2011-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

• Women indicated for a first IVF/ICSI treatment
• Primary or secondary infertility
• Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle

Exclusion Criteria

• Recurrent miscarriage
• Prior hysteroscopy treatments
• Meno-metrorrhagia (defined as any intermenstrual loss of blood)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional diagnostic tests	Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))	Participants in the experimental arm will undergo standard hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities. In two of the participating clinics, also a 'Saline Infusion Sonography' (SIS) will be performed, 1 week before the hysteroscopy. After the additional diagnostic test(s), standard IVF/ICSI treatment will be initiated.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy	18 months	Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

Secondary Outcome Measures

Name	Time	Method
Costs	24 months	Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
Implantation rate	18 months	Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomisation (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
Patient tolerance	24 months	Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
Prevalence of unexpected intrauterine abnormalities	3 months
Miscarry rate	18 months	Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomisation (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
Diagnostic accuracy of SIS	3 months

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands