Waterhoudend contrast versus oliehoudend contrast voor het doorspuiten van de eileiders tijdens een baarmoederfoto - de lange termijn effecten.

OIL - BASED CONTRAST VERSUS WATER BASED CONTRAST MEDIA IN THE DIAGNOSIS OF TUBAL PATENCY AT HYSTEROSALPINGOGRAPHY: H2Oil trial – long term follow-up.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24080

Enrollment

1119

Registered

2017-07-19

Start date

2017-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility H2Oil Hysterosalpingography HSG Oil-based contrast medium Water-based contrast medium Tubal patency testing

Interventions

After given informed consent, women will be asked to fill in the questionnaire and return it.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Ongoing pregnancy rate following HSG.	—

Secondary

Measure	Time frame
Biochemical pregnancy, clinical pregnancy, miscarriage, ectopic pregnancy, multiple pregnancy, time from randomization to ongoing pregnancy, received fertility treatments, mode of conception, complications during pregnancy and delivery, neonatal outcomes, the aim and ability to get a second child, cost calculations of oil based contrast / water based contrast and assisted reproductive technology (ART) treatments.	—

Measure

Time frame

Biochemical pregnancy, clinical pregnancy, miscarriage, ectopic pregnancy, multiple pregnancy, time from randomization to ongoing pregnancy, received fertility treatments, mode of conception, complications during pregnancy and delivery, neonatal outcomes, the aim and ability to get a second child, cost calculations of oil based contrast / water based contrast and assisted reproductive technology (ART) treatments.

—

Contacts

Public ContactJ. van Rijswijk

VUmc - Voortplantingsgeneeskunde De Boelelaan 1118, PK 5 X 194, 1081 HZ Amsterdam

j.vanrijswijk@vumc.nl020-4445277

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)