Status:
ACTIVE_NOT_RECRUITING
Live Birth After Additional Tubal Flushing With Oil-based Contrast Versus no Additional Flushing:
Lead Sponsor:
Dafne Balemans
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Ten to 15 percent of couples in their reproductive lifetime face fertility problems which is defined by WHO as the absence of pregnancy after minimal 12 months of unprotected sexual intercourse. The t...
Eligibility Criteria
Inclusion
- Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they
- are ≥ 18 years and \< 40 years
- have infertility defined as
- lack of conception despite 12 months of unprotected intercourse OR;
- if they are taking part in a donor sperm insemination programme: three cycles of donor insemination without pregnancy OR;
- in case of treated ovulation disorder: three ovulatory ovulation induction cycles without pregnancy
- have tubal patency of at least one Fallopian tube on Hyfosy
Exclusion
- Women with
- known iodine allergy
- allergy to poppy seed oil
- ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction
- contra-indication to have tubal patency testing according to the site's indication
- active thyroid disorders
- untreated subclinical hypothyroidism (TSH\>2.5mIU/L) in case of auto-immune thyroid disease
- uterine surgery in the past two months before Hyfosy
- a male partner (if applicable)
- with a post-wash Total Motile Sperm Count (TMC) \< 1x106 and/or TMC \< 3x106 in the native sperm analysis \[TMC is defined as volume X concentration X (A\* (progressive) + B\* (non progressive) motility in %) divided by 100\] OR
- with a history suspect of severe male factor infertility if no sperm sample is available at time of randomisation
- an indication for IVF defined as patients who are advised to go to IVF immediately because of bilateral tubal block, severe male factor infertility, unsolved anovulatory problems, endometriosis with residual functional problems"
- no Belgian national number (RRN/INS)
- A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021)
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
736 Patients enrolled
Trial Details
Trial ID
NCT04379973
Start Date
May 25 2021
End Date
June 1 2027
Last Update
November 20 2025
Active Locations (16)
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1
Antwerp University Hospital
Antwerp, Belgium
2
GZA Sint Augustinus
Antwerp, Belgium
3
Imelda
Bonheiden, Belgium
4
AZ Klina
Brasschaat, Belgium