SIGnificance of routine Hysteroscopy prior to a first 'in vitro fertilization' (IVF) Treatment cycle

Completed

• Conditions: Intrauterine abnormalities; 10046828; intracavitary pathology; 10010273

• Registration Number: NL-OMON39052
• Lead Sponsor: Divisie Vrouw en Baby

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 740

Inclusion Criteria

Women indicated for a first IV/'intracytoplasmic sperm injection' (ICSI) treatment
Primary or secondary infertility
Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle

Exclusion Criteria

Recurrent miscarriage (defined as two or more miscarriages prior to the 20th week of gestation)
Prior hysteroscopy treatments
Meno-metrorrhagia (defined as any intermenstrual loss of blood)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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