Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study)
Introduction Hysterosalpingography (HSG) and hysterosalpingo-foam sonography (HyFoSy) are commonly used tubal patency tests during the fertility work-up. Besides its diagnostic purpose, HSG with oil-based contrast can also be applied for its fertility-enhancing effect, by tubal flushing. HyFoSy is c...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/11/e091778.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850176689863131136 |
|---|---|
| author | Madelon van Wely Harold R Verhoeve Judith E Bosmans Johannes R Anema Jan Peter de Bruin Jaap Stoker Ben Willem J Mol Danah Kamphuis Janette P M Huijser Nienke van Welie Esther Kuijper Angelique J C M van Dongen Susanne C J P Gielen Guusje de Krom Femi Janse Carolien A M Koks Annemiek W Nap Velja Mijatovic Kim Dreyer |
| author_facet | Madelon van Wely Harold R Verhoeve Judith E Bosmans Johannes R Anema Jan Peter de Bruin Jaap Stoker Ben Willem J Mol Danah Kamphuis Janette P M Huijser Nienke van Welie Esther Kuijper Angelique J C M van Dongen Susanne C J P Gielen Guusje de Krom Femi Janse Carolien A M Koks Annemiek W Nap Velja Mijatovic Kim Dreyer |
| author_sort | Madelon van Wely |
| collection | DOAJ |
| description | Introduction Hysterosalpingography (HSG) and hysterosalpingo-foam sonography (HyFoSy) are commonly used tubal patency tests during the fertility work-up. Besides its diagnostic purpose, HSG with oil-based contrast can also be applied for its fertility-enhancing effect, by tubal flushing. HyFoSy is considered as less painful compared with HSG, it lacks exposure to iodinated contrast medium and ionising radiation. The fertility-enhancing effects of HyFoSy are less studied and randomised controlled trials comparing pregnancy rates after HSG and HyFoSy are lacking. This study (FOil study) is initiated to compare the effectiveness of tubal flushing during HSG with oil-based contrast and HyFoSy.Methods and analysis The FOil study is a nationwide, multicentre, open label, randomised controlled trial with a superiority design. Infertile women with an indication for tubal patency testing during their fertility work-up will be randomly assigned to HSG with oil-based contrast medium or HyFoSy. The primary outcome is conception within 6 months after randomisation leading to live birth. To demonstrate or refute an 8% difference in conception leading to live birth in favour of HSG with oil-based contrast, 1102 women will be included in the trial. A cost-effectiveness analysis from a societal perspective will be performed alongside the trial.Ethics and dissemination The trial is approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers (Ref. No. 2022.0884, date: 17 March 2023) and by the boards of the participating hospitals. The findings will be disseminated in peer-reviewed journals and participants will be informed through the patient organisation.Trial registration number NCT05882188. |
| format | Article |
| id | doaj-art-af982b0f459d4b32b9c5877af4a7c51d |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-af982b0f459d4b32b9c5877af4a7c51d2025-08-20T02:19:12ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-091778Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study)Madelon van Wely0Harold R Verhoeve1Judith E Bosmans2Johannes R Anema3Jan Peter de Bruin4Jaap Stoker5Ben Willem J Mol6Danah Kamphuis7Janette P M Huijser8Nienke van Welie9Esther Kuijper10Angelique J C M van Dongen11Susanne C J P Gielen12Guusje de Krom13Femi Janse14Carolien A M Koks15Annemiek W Nap16Velja Mijatovic17Kim Dreyer1815 Centre for Reproductive Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands3 Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands13 Department of Health Sciences, Faculty of Science, Amsterdam Public Health, research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands12 Public and Occupational Health, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands5 Obstetrics and Gynaecology, Jeroen Bosch Hospital, `s-Hertogenbosch, The Netherlands14 Radiology and Nuclear Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands16 Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia1 Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands2 Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands1 Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands4 Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands6 Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, The Netherlands7 Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, The Netherlands8 Obstetrics and Gynaecology, Zuyderland Medical Center, Heerlen, The Netherlands9 Obstetrics and Gynaecology, Rijnstate, Arnhem, The Netherlands10 Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands11 Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands1 Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands1 Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The NetherlandsIntroduction Hysterosalpingography (HSG) and hysterosalpingo-foam sonography (HyFoSy) are commonly used tubal patency tests during the fertility work-up. Besides its diagnostic purpose, HSG with oil-based contrast can also be applied for its fertility-enhancing effect, by tubal flushing. HyFoSy is considered as less painful compared with HSG, it lacks exposure to iodinated contrast medium and ionising radiation. The fertility-enhancing effects of HyFoSy are less studied and randomised controlled trials comparing pregnancy rates after HSG and HyFoSy are lacking. This study (FOil study) is initiated to compare the effectiveness of tubal flushing during HSG with oil-based contrast and HyFoSy.Methods and analysis The FOil study is a nationwide, multicentre, open label, randomised controlled trial with a superiority design. Infertile women with an indication for tubal patency testing during their fertility work-up will be randomly assigned to HSG with oil-based contrast medium or HyFoSy. The primary outcome is conception within 6 months after randomisation leading to live birth. To demonstrate or refute an 8% difference in conception leading to live birth in favour of HSG with oil-based contrast, 1102 women will be included in the trial. A cost-effectiveness analysis from a societal perspective will be performed alongside the trial.Ethics and dissemination The trial is approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers (Ref. No. 2022.0884, date: 17 March 2023) and by the boards of the participating hospitals. The findings will be disseminated in peer-reviewed journals and participants will be informed through the patient organisation.Trial registration number NCT05882188.https://bmjopen.bmj.com/content/14/11/e091778.full |
| spellingShingle | Madelon van Wely Harold R Verhoeve Judith E Bosmans Johannes R Anema Jan Peter de Bruin Jaap Stoker Ben Willem J Mol Danah Kamphuis Janette P M Huijser Nienke van Welie Esther Kuijper Angelique J C M van Dongen Susanne C J P Gielen Guusje de Krom Femi Janse Carolien A M Koks Annemiek W Nap Velja Mijatovic Kim Dreyer Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) BMJ Open |
| title | Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) |
| title_full | Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) |
| title_fullStr | Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) |
| title_full_unstemmed | Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) |
| title_short | Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study) |
| title_sort | tubal flushing with oil based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo foam sonography in infertile women undergoing fertility work up study protocol of a randomised controlled trial foil study |
| url | https://bmjopen.bmj.com/content/14/11/e091778.full |
| work_keys_str_mv | AT madelonvanwely tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT haroldrverhoeve tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT judithebosmans tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT johannesranema tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT janpeterdebruin tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT jaapstoker tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT benwillemjmol tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT danahkamphuis tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT janettepmhuijser tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT nienkevanwelie tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT estherkuijper tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT angeliquejcmvandongen tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT susannecjpgielen tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT guusjedekrom tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT femijanse tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT carolienamkoks tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT annemiekwnap tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT veljamijatovic tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy AT kimdreyer tubalflushingwithoilbasedcontrastduringhysterosalpingographyversustubalflushingbyhysterosalpingofoamsonographyininfertilewomenundergoingfertilityworkupstudyprotocolofarandomisedcontrolledtrialfoilstudy |