RecruitingPhase 3ACTRN12621001164886

A Randomised Controlled Feasibility Trial of the Mechanisms of the Fertility Enhancing Effect of Lipiodol in Women

A Randomised Controlled Feasibility Trial of the Mechanisms of the Fertility Enhancing Effect of Lipiodol in Women Undergoing Hysterectomy for Benign Gynaecological Disease

Sponsor

Professor Neil Johnson

Enrollment

45 participants

Start Date

Aug 2, 2021

Study Type

Interventional

Conditions

Endometriosis Subfertility

Summary

Lipiodol, an oil soluble contrast medium (OSCM) has a clear fertility enhancing effect, but its mechanism of action is uncertain. This trial seeks to determine the feasibility, from both the clinical perspective and the laboratory perspective, of changes brought about by lipiodol within the endometrium, the fallopian tubes and the peritoneal lining. Establishing the variables within these tissues that demonstrate the trends of effect of largest magnitude when women who have had a lipiodol hysterosalpingogram (HSG) are compared to women who have had an HSG with a water soluble contrast medium (WSCM), and when women who have had a lipiodol HSG are compared to women who have had no intervention, is likely to point towards candidate mechanisms. This pilot randomised controlled trial (RCT) will then inform the feasibility of testing such variables in a definitive RCT of women with infertility that could, in the future, assess whether such changes are associated with a successful fertility outcome. Future RCTs examining the fertility efficacy of lipiodol could then endeavour to link fertility efficacy to the candidate mechanism as part of the entire RCT or within a cohort of women who form part of the overall RCT group, but in whom the mechanisms of lipiodol are also sought.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 49 Yearss

Plain Language Summary

Simplified for easier understanding

Lipiodol is an oil-based contrast dye used in a fertility procedure called a hysterosalpingogram (HSG) — a test that checks whether the fallopian tubes are open. For decades, doctors have noticed that some women become pregnant more easily after having this oil-based dye test — a surprising 'fertility bonus' effect. Despite this being well-documented, nobody fully understands why it happens. This feasibility study will look for biological clues by examining tissue samples from the uterus (endometrium), fallopian tubes, and peritoneal lining in women who have had a lipiodol HSG, a water-soluble contrast HSG, or no HSG at all, prior to undergoing a hysterectomy. The goal is to identify which tissue-level changes are most strongly linked to the lipiodol effect. You may be eligible if you are a woman under 50 years old with a regular menstrual cycle suggesting ovulation and are scheduled for a hysterectomy for a benign (non-cancerous) gynaecological reason. Women with large fibroids (over 10cm), known malignancy, sexually transmitted infections, or those scheduled for a purely vaginal hysterectomy are not eligible.

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Interventions

Women of reproductive age (<50 years) and who have a regular cycle that suggests ovulation, who are due to undergo hysterectomy for benign gynaecologcical conditions, will be recruited into the study. Following ethical approval and in the context of fully informed and written consent, 45 women will be randomised to one of three groups (n = 15 per group) in one single block of n=45 in a parallel-group design. In the follicular phase of the cycle prior to hysterectomy Group 1 will receive a Lipiodol hysterosalpingogram (HSG), Group 2 will receive a control water soluble contrast media HSG and Group 3 will receive no intervention. The dose of administered Lipiodol will not exceed 10mL in each case for each patient, with the duration of administration being confined to time of HSG procedure only (once off use). The mode of administration is via instillation through the cervical canal into the cervix and follopian tubes via a hysterosalpingography (HSG) procedure. The attending Radiologist/physician will determine the exact dose of administered Lipiodol at the time of a HSG procedure. The minimum dose of Lipiodol to be administered above 5mL (including dead-volume in catheter) and until Lipiodol spill through the fimbriae is visualised by attending specialist radiologist under flouroscopy. A participant’s HSG procedure can vary in length, depending on clinical conditions between patients, however is not expected to exceed 20 mins in duration. A specialist Radiologist will administer the HSG procedure. The mode of administration is via instillation through the cervical canal using either a) Leech Wilkinson Cannula, or b) Cook Ballloon HSG Catheter, or c) a Rocket HSG Catheter. The type of water soluble contrast media utilised will be either Telebrix Hystero or agitated saline (which ever method is preferred by the Radiologist and in accordance to local protocol for HSG). The water soluble contrast media will be administered as per the lipidol administration procedure, the minimum dose will be above 5mL. All HSG procedures completed by the respective Radiologists in each center will follow a clearly stipulated protocol for HSG as described above. Any deviations will be recorded by the attending radiologist and reported immediately to the trial coordinator.