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
Conditions
Interventions
Trade Name: Lipiodol
Product Name: Lipiodol Ultrafluid
Pharmaceutical Form: Injection
Sponsors
Amsterdam UMC - location Vrije Universiteit Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.;Secondary Objective: Treatment outcome parameters: - Live birth - Clinical pregnancy - Ongoing pregnancy - Miscarriage - Ectopic pregnancy - Multiple pregnancy - Complications following HSG (infection, intravastion) - Pregnancy outcomes (f.e. birth weight) - Pregnancy complications - Stillbirth - Thyroid function of the woman (before and 1 month after HSG) - Neonatal outcomes - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI) - Thyroid function of neonate (determined by heelprick) - Level of anxiety and pain during HSG Cost-effectiveness: - Direct and indirect costs of treatment within 12 months after randomization;Primary end point(s): The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.;Timepoint(s) of evaluation of this end point: 12 months after randomization, unless a patient is pregnant within the 12 months follow-up, then she will be followed untill the end of the pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Live birth - Clinical pregnancy - Ongoing pregnancy - Miscarriage - Ectopic pregnancy - Multiple pregnancy - Complications following HSG (infection, intravastion) - Pregnancy outcomes (f.e. birth weight) - Pregnancy complications - Stillbirth - Thyroid function of the woman (before and 1 month after HSG) - Neonatal outcomes - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI) - Costs within 12 months after randomization - Thyroid function of neonate (determined by heelprick) - Level of anxiety and pain during HSG;Timepoint(s) of evaluation of this end point: T0: Time of randomization T1: Six months after randomization T2: Twelve months after randomization, unless a patient is pregnant within the 12 months follow-up, then she will be followed untill the end of the pregnancy. | — |
Countries
Netherlands
Contacts
Public Contactdr. V. Mijatovic
Amsterdam UMC - location Vrije Universiteit Amsterdam
Outcome results
None listed