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A study concerning the influence of tubal flushing with oil on pregnancy and live birth in women with fertility problems
EU CTIS ID: 2023-508896-35-00
What this study is testing
To determine if the additional tubal flushing with oil-based contrast after undergoing Hyfosy significantly improves the occurrence rate of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy compared to no additional flushing after undergoing Hyfosy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they (1) are ≥ 18 years and < 40 years
- (2) 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
- (3) have tubal patency of at least one Fallopian tube on Hyfosy
You likely can't join if
- known iodine allergy
- no Belgian national number (RRN/INS)
- 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
See the full eligibility criteria
- Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they (1) are ≥ 18 years and < 40 years
- (2) 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
- (3) have tubal patency of at least one Fallopian tube on Hyfosy
- known iodine allergy
- no Belgian national number (RRN/INS)
- 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 (*A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021))
- 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”
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.