This study has been transitioned to CTIS with ID 2024-512571-12-00 check the CTIS register for the current data. The objective of the proposed study is to assess the effectiveness and cost-effectiveness of the use of oil versus water-based contrast…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is conception leading to live birth within 6 months after
randomization.
Secondary outcome
- Biochemical pregnancy
- 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 6 months after randomization
- Thyroid function of neonate (determined by heelprick)
Background summary
Staying childless, due to the inability to conceive, is one of life*s great
misfortunes. Infertility, defined as the inability to conceive within 1 year of
unprotected intercourse, affects 1 out of 6. Hysterosalpingography (HSG), a
test to assess tubal patency, is commonly part of the fertility work-up offered
to patients presenting with infertility. HSG was initially introduced as a
diagnostic test to evaluate the patency of the Fallopian tubes. The past
decades there have been debates of therapeutic effects of tubal flushing during
HSG, especially with oil-based contrast. The latest Cochrane
systematic reviews showed a non-significant difference in ongoing pregnancies
in favor of tubal flushing with oil-based contrast in infertile women
(Mohiyiddeen et al., 2015). To illuminate the uncertainty on the use of oil- or
water-based contrast for HSG, our group conducted a large robust multicenter
randomized controlled trial, the H2Oil study, in which 1.119 infertile women
participated. This landmark study, published last year in the NEJM, showed
significantly more ongoing pregnancies in the first 6 months following HSG with
oil-based contrast as compared to HSG with waterbased contrast (RR 1.38; 95%
CI, 1.17 to 1.64; P<0.001) (Dreyer et al., 2017). Publication of the study
generated a world-wide renewed interest in tubal flushing and the use of
oil-based contrast for fertility enhancement. However, the H2Oil study was
limited by inclusion of women between 18 and 38 years of age, with a
spontaneous regular menstrual cycle and at low risk for tubal pathology. As
indicated above however, anovulation and tubal pathology are important causes
of infertility. Furthermore, increasing female age is one of the main causes of
infertility in the 21st century, with > 500 of the women undergoing IVF being
over 35 years of age. As a consequence, the results of our H2Oil study are not
applicable to more than 50% of the population of infertile women seen in
fertility clinics in The Netherlands.
Study objective
This study has been transitioned to CTIS with ID 2024-512571-12-00 check the CTIS register for the current data.
The objective of the proposed study is to assess the effectiveness and
cost-effectiveness of the use of oil versus water-based contrast medium in
terms of live birth in women undergoing HSG, who:
1: have ovulation disorders or;
2: are at high risk for tubal pathology or;
3: are above 38 years of age.
Study design
Multi-center randomized controlled trial with an economic analysis alongside
it.
Intervention
We will compare tubal flushing with oil-based contrast (intervention) versus
tubal flushing with water-based contrast (control).
Study burden and risks
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.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Women:
1: with ovulation disorders (defined as less than 8 menstrual cycles per year)
or;
2: at high risk for tubal pathology (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: above 38 years of age
Exclusion criteria
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 1 x106
spermatozoa/ml
- Not willing or able to sign the consent form
- Endocrine disorder as diabetes, hyperthyroidism or hyperprolactinaemia except
for well managed hypothyroidism (TSH between 0.3 and 2.5mIU/l)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-512571-12-00 |
| EudraCT | EUCTR2018-004192-12-NL |
| CCMO | NL66079.029.19 |
| Other | NTR NL7925 |
| OMON | NL-OMON24142 |