Background: Tubal pathology is a causative factor in 20% of subfertile couples. Traditionally, tubal testing during fertility work-up is performed by hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly. HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes. Methods/design: We aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG. Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up. The study group will consist of 1163 subfertile women between 18 and 41years old who are scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male subfertility or a known contrast (iodine) allergy will be excluded. We anticipate that 7 % (N=82) of the participants will have discordant test results for HyFoSy and HSG. These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromopertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management). The primary outcome is ongoing pregnancy leading to live birth within 12months after randomization. Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments. Costs will be estimated by counting resource use and calculating unit prices. Discussion: This trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women.
Bibliographical noteThis is an investigator initiated trial, VU medical center Amsterdam is the sponsor, contact information: prof. CJM de Groot, Department of Obstetrics and Gynaecology, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands, Tel: + 31-204444444. This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 837001504. ZonMW gives financial support for the whole project. IQ Medical Ventures provides the ExEm FOAM® kits. The funding bodies have no role in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript.
Data Availability StatementAvailability of data and materials
Data entry and secure storage is performed with data management system OpenClinica (OpenClinica LLC and collaborators, by TraIT (Translational Research IT infrastructure), version: 3.6). In each of the participating center, data entry according to Good Clinical Practice (GCP) was performed by dedicated research nurses, fertility doctors or gynecologists. Data control during the trial is possible. Monitoring will be performed in compliance with GCP and other rules and regulations in order to achieve high quality research and secure patient safety. Qualified and independent monitors from the NVOG Consortium will have access to the data and source documents of the trial. Based on the Site Specific Monitoring program of the NVOG Consortium, site evaluation visits will be performed to review the quality of the participating sites. For more detailed information see: NVOG Consortium 2.0, site specifiek evaluatie-en monitorplan, versie 2.0 (K6).The quality advisor will also perform data verification at the end of the trial. JvR, NvW, KD and VM will have access to the final dataset.
- Budget impact
- Fertility work-up
- Hysterosalpingo foam sonography (HyFoSy)
- Hysterosalpingography (HSG)
- Ongoing pregnancy
- Randomized controlled trial
- Tubal patency testing