Evaluation of Ethyl Esters of Iodised Fatty Acids from Poppyseed Oil in Tubal Flushing for Infertility in Women with Patent Tubes at HyFoSy

The primary objective of this study is to evaluate whether **additional tubal flushing** with an oil-based contrast agent, specifically Lipiodol Ultra-Fluide, following Hysterosalpingo-foam sonography (Hyfosy) significantly enhances the rate of live births. This is measured from the first day of the last menstrual cycle in which conception occurs within six months post-Hyfosy, compared to no additional flushing. This objective is clinically relevant as it seeks to improve fertility outcomes in women with at least one patent tube, potentially offering a non-invasive intervention to increase the likelihood of achieving a live birth.

The clinical trial involves a study population of **infertile women** aged 18 to 39 years, who are undergoing Hysterosalpingo-foam sonography (Hyfosy) as part of their fertility workup. The trial specifically includes women who have at least one patent Fallopian tube as confirmed by Hyfosy. Participants are selected based on their infertility status, defined as a lack of conception despite 12 months of unprotected intercourse, or specific criteria related to donor sperm insemination or treated ovulation disorders. The trial does not include male subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of additional **tubal flushing** with oil-based contrast in improving live birth rates among infertile women with at least one patent tube, as determined by **Hysterosalpingo-foam sonography** (Hyfosy). This is a randomized, multicenter, parallel-group pragmatic trial. The study will employ a double-blind methodology to ensure unbiased results, with participants randomly assigned to either the intervention group receiving the oil-based contrast or the control group with no additional flushing. The trial is expected to span from June 2021 to October 2026, with participant involvement lasting up to six months post-Hyfosy.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18-39 years), infertility status, and tubal patency. Follow-up visits will be scheduled to monitor the participants' progress and collect data on conception and pregnancy outcomes. The primary endpoint is the occurrence of live birth within six months of the last menstrual cycle in which conception occurs. The end-of-study visit will conclude the participant's involvement, assessing the final outcomes and any adverse events.

Participants may be withdrawn from the study if they no longer meet the inclusion criteria, experience significant adverse effects, or choose to discontinue participation. The trial's primary objective is to determine whether the additional tubal flushing with oil-based contrast significantly improves live birth rates compared to no additional flushing. The study will utilize **Lipiodol Ultra-Fluide**, a solution for injection containing **ethyl esters of iodised fatty acids from poppyseed oil**, administered via intrauterine use. The maximum daily and total dose is 4800 mg, with a treatment period limited to one day. This trial is categorized as a Phase IV trial, indicating it is conducted post-marketing to gather further information on the product's effectiveness and safety.

The clinical trial involves the use of **Lipiodol Ultra-Fluide**, a solution for injection containing **ethyl esters of iodised fatty acids from poppyseed oil**. This experimental medication is administered via **intrauterine use**. The pharmaceutical form of the product is a solution injectable, with a concentration of 480 mg I/ml. The maximum daily dose and total dose amount to 4800 mg, with the treatment period limited to one day. The product is manufactured by Guerbet and is not a paediatric formulation. The primary objective of the trial is to assess the efficacy of additional tubal flushing with this oil-based contrast in improving live birth rates in infertile women.

In this study, the experimental treatment is compared against a control group receiving no additional flushing after undergoing Hysterosalpingo-foam sonography (Hyfosy). The trial is designed as a randomised, multicentre, parallel group pragmatic trial. The control group serves as a comparator to evaluate the effectiveness of the experimental treatment in achieving the main objective of the study. Participant compliance with the treatment protocol is monitored throughout the trial to ensure accurate assessment of the treatment's efficacy.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the occurrence of **live birth**. This will be measured from the first day of the last menstrual cycle in which the patient conceives within six months after undergoing Hysterosalpingo-foam sonography (Hyfosy). The trial aims to determine if additional tubal flushing with oil-based contrast significantly improves the live birth rate compared to no additional flushing after Hyfosy. The assessment will focus on infertile women with at least one patent Fallopian tube, who are undergoing Hyfosy as part of their fertility workup. The trial is designed as a randomized, multicenter, parallel group pragmatic trial. The efficacy parameters will be collected and analyzed over the course of the trial, with the estimated end date set for October 31, 2026.