ETHYL ESTERS OF IODISED FATTY ACIDS FROM POPPYSEED OIL for Infertility

Inclusion criteria

• {"criterion_text":"- Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they (1) are ≥ 18 years and < 40 years\n- (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\n- (3) have tubal patency of at least one Fallopian tube on Hyfosy"}

Exclusion criteria

• {"criterion_text":"- known iodine allergy\n- no Belgian national number (RRN/INS)\n- allergy to poppy seed oil\n- ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction\n- contra-indication to have tubal patency testing according to the site’s indication\n- active thyroid disorders\n- untreated subclinical hypothyroidism (TSH>2.5mIU/L) in case of auto-immune thyroid disease\n- uterine surgery in the past two months before Hyfosy\n- 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))\n- 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”"}

Primary endpoints

• {"endpoint_text":"- the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.","definition_or_measurement_approach":"Occurrence of live birth within 6 months after HyFoSy, counting from the first day of the last menstrual cycle in which the patient conceives."}

Belgium

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

13-12-2024

Processing Time Days

165

Number Of Sites

14

Number Of Participants

736

Primary sponsor

Full Name

Antwerp University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium