The primary hypothesis is that the effect of tubal flushing with oil-based contrast results in higher ongoing pregnancy rates compared to water-based contrast medium.
ID
Bron
Verkorte titel
Aandoening
Subfertility
H2Oil
Hysterosalpingography
HSG
Oil-based contrast medium
Water-based contrast medium
Tubal patency testing
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ongoing pregnancy rate following HSG.
Achtergrond van het onderzoek
Recently, we published the H2Oil study: Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile women. The ongoing pregnancy rates within six monhts after randomization were 39.7% in the oil-group compared to 29.1% in the water-group. At six months, this difference between tubal flushing with lipiodol and water based contrast was still increasing. Firstly, it is unclear if this difference will increase beyond 6 months. Secondly, it is unclear if couples after having had a first child, still benefit from the single procedure of tubal flushing when they aim to get a second child. Thirdly, the economic impact of the use of oil-based contrast is unclear. It is likely that the 6 month difference in pregnancy rate will result in a decrease of the use of additional treatments, of which IVF is the most important one.
Based on these three questions, we propose a long-term follow-up of couples that participated in the H2Oil study.
Doel van het onderzoek
The primary hypothesis is that the effect of tubal flushing with oil-based contrast results in higher ongoing pregnancy rates compared to water-based contrast medium.
Onderzoeksopzet
Follow-up until 3 to 5 years after randomization.
Onderzoeksproduct en/of interventie
After given informed consent, women will be asked to fill in the questionnaire and return it.
Publiek
De Boelelaan 1118, PK 5 X 194, 1081 HZ Amsterdam
J. van Rijswijk
Postbus 7057, 1007 MB Amsterdam
Amsterdam
The Netherlands
020-4445277
j.vanrijswijk@vumc.nl
Wetenschappelijk
De Boelelaan 1118, PK 5 X 194, 1081 HZ Amsterdam
J. van Rijswijk
Postbus 7057, 1007 MB Amsterdam
Amsterdam
The Netherlands
020-4445277
j.vanrijswijk@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Participants of the Water- versus Oil (H2Oil) study who were recruited in 27 hospitals (4 academic, 12 teaching and 11 non-teaching hospitals) in the Netherlands, between February 2012 and October 2014.
Inclusion criteria of the H2Oil study:
1. Age between 18 up to and including 39 years;
2. Subfertility of at least one year;
3. Chlamydia antibody titer (CAT) negative;
4. Low risk of tubal pathology according to the medical history;
5. Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria of the H2Oil study:
1. Endocrino-pathological diseases as: PCOS, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type 1;
2. Known or high risk for tubal pathology, CAT positive;
3. Known contrast (iodine) allergy;
4. Male subfertility defined as a post-wash total motile sperm count < 3x10.6 spermatozoa/ml;
5. If not willing or able to sign the consent form.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6402 |
| NTR-old | NTR6577 |
| Ander register | 2017.221 : VU University Medical Centre |
Samenvatting resultaten
Kieslinger DC, .. van Rijswijk J et al. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016;31(11):2450-2457.<br>
Becker JH, van Rijswijk J et al. Is intrapartum fever associated with ST-waveform changes of the fetal electrocardiogram? A retrospective cohort study. BJOG. 2012;119(11):1410-6.