ive birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel group pragmatic trial in infertile women with at least one patent tube at Hysterosalpingo-foam sonography - HYFOI

Antwerp University Hospital0 个研究点目标入组 736 人开始时间: 2024年6月19日最近更新: 2024年7月22日

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•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”

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