TY - JOUR
T1 - The FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women?
T2 - Study protocol for a randomized controlled trial
AU - van Rijswijk, Joukje
AU - van Welie, Nienke
AU - Dreyer, Kim
AU - van Hooff, Machiel H. A.
AU - de Bruin, Jan Peter
AU - Verhoeve, Harold R.
AU - Mol, Femke
AU - Kleiman-Broeze, Kimiko A.
AU - Traas, Maaike A. F.
AU - Muijsers, Guido J. J. M.
AU - Manger, Arentje P.
AU - Gianotten, Judith
AU - de Koning, Cornelia H.
AU - Koning, AafkeM. H.
AU - Bayram, Neriman
AU - van der Ham, David P.
AU - Vrouenraets, Francisca P. J. M.
AU - Kalafusova, Michaela
AU - van de Laar, Bob I. G.
AU - Kaijser, Jeroen
AU - van Oostwaard, Miriam F.
AU - Meijer, Wouter J.
AU - Broekmans, Frank J. M.
AU - Valkenburg, Olivier
AU - van der Voet, Lucy F.
AU - van Disseldorp, Jeroen
AU - Lambers, Marieke J.
AU - Peters, Henrike E.
AU - Lier, Marit C. I.
AU - Lambalk, Cornelis B.
AU - van Wely, Madelon
AU - Bossuyt, Patrick M. M.
AU - Stoker, Jaap
AU - van der Veen, Fulco
AU - Mol, Benw. J.
AU - Mijatovic, Velja
PY - 2018/5/9
Y1 - 2018/5/9
N2 - 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 41 years 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 12 months 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.
AB - 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 41 years 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 12 months 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.
KW - Hysterosalpingo foam sonography (HyFoSy)
KW - Hysterosalpingography (HSG)
KW - Fertility work-up
KW - Tubal patency testing
KW - Ongoing pregnancy
KW - Cost effectiveness
KW - Subfertility
KW - Randomized controlled trial
KW - Budget impact
KW - HEALTH SURVEY
KW - VALIDATION
KW - SF-36
U2 - 10.1186/s12905-018-0556-6
DO - 10.1186/s12905-018-0556-6
M3 - Article
C2 - 29743106
SN - 1472-6874
VL - 18
SP - 1
EP - 7
JO - BMC Women's Health
JF - BMC Women's Health
IS - 64
M1 - 64
ER -