What is the best moment for performing an HSG in women with a unfulfilled childwish?

Phase 1

• Conditions: The research population consists of infertile women aged between 18 and 39 years of age, who have a spontaneous menstrual cycle and with a perceived low risk for tubal pathology, undergoing fertility work-up; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-004153-24-NL
• Lead Sponsor: Amsterdam UMC - location Vrije Universiteit Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 554

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 554
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
- Ovulation disorders defined as less than eight menstrual cycles per year
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified