No registrations found.
ID
Source
Brief title
Health condition
Subfertility, tubal patency testing
Sponsors and support
Intervention
Outcome measures
Primary outcome
Conception leading to live birth with a positive pregnancy test within 6 months after randomization.
Secondary outcome
- Biochemical pregnancy, clinical pregnancy, ongoin pregnancy
- Miscarriage, ectopic pregnancy, multiple pregnancy
- Time to 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 6 months after randomization
- Thyroid function of neonate (determined by heelprick)
Background summary
Rationale: We hypothesize that tubal flushing at hysterosalpingography (HSG) with oil-based contrast will result in higher pregnancy and live birth rates as compared to tubal flushing at HSG with water-based contrast in women: with an ovulation disorder, at high risk for tubal pathology and/or ≥38 years of age, which will lead to a reduction in the need for expensive fertility treatments like IVF and/or ICSI, and will therefore be a cost effective strategy.
Objective: The objective of the proposed study is to assess the effectiveness and costeffectiveness of the use of oil versus water-based contrast medium in terms of live birth in women undergoing HSG, who:
1: have ovulation disorders and/or;
2: are at high risk for tubal pathology and/or;
3: are 39 years of age or over.
Study design: Multicenter, randomized controlled trial with a cost-effectiveness analysis alongside it.
Study population:
We will study women:
1: with ovulation disorders and/or;
2: at high risk for tubal pathology and/or;
3: are 39 years of age or over.
Intervention: We will compare tubal flushing at HSG with oil-based contrast (intervention) versus tubal flushing with water-based contrast (control).
Main study parameters/endpoints: The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
We will also study time-to-pregnancy. Our hypothesis is that HSG with oil-based contrast will increase pregnancy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As we compare strategies (HSG with oil-based contrast versus HSG with water-based contrast) that are already applied in current practice, no additional risks or burdens are expected from the study.
Study objective
We hypothesize that tubal flushing at hysterosalpingography (HSG) with oil-based contrast will result in higher pregnancy and live birth rates as compared to tubal flushing at HSG with water-based contrast in the target population.
Study design
Follow-up 6 months after randomization
Intervention
HSG as tubal patency test with oil-based contrast versus HSG as tubal patency test with water-based contrast.
Inclusion criteria
In order to be eligible to participate in this study, women must meet one of the following criteria:
1: with ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year) or;
2: at high risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or;
3: 39 years of age or over
Exclusion criteria
- Iodinated contrast agent allergy
- Male subfertility defined as total motile sperm count < 3 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7925 |
| CCMO | NL66079.029.19 |
| OMON | NL-OMON52387 |