The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination

N. A. Danhof; M. van Wely; C. A. M. Koks; J. Gianotten; J. P. de Bruin; B. J. Cohlen; D. P. van der Ham; N. F. Klijn; M. H. A. van Hooff; F. J. M. Broekmans; K. Fleischer; C. A. H. Janssen; J. M. Rijn van Weert; J. van Disseldorp; M. Twisk; M. Traas; M. F. G. Verberg; M. J. Pelinck; J. Visser; D. A. M. Perquin; D. E. S. Boks; H. R. Verhoeve; C. F. van Heteren; B. W. J. Mol; S. Repping; F. van der Veen; M. H. Mochtar

doi:https://doi.org/10.1136/bmjopen-2016-015680

The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination

N. A. Danhof, M. van Wely, C. A. M. Koks, J. Gianotten, J. P. de Bruin, B. J. Cohlen, D. P. van der Ham, N. F. Klijn, M. H. A. van Hooff, F. J. M. Broekmans, K. Fleischer, C. A. H. Janssen, J. M. Rijn van Weert, J. van Disseldorp, M. Twisk, M. Traas, M. F. G. Verberg, M. J. Pelinck, J. Visser, D. A. M. PerquinD. E. S. Boks, H. R. Verhoeve, C. F. van Heteren, B. W. J. Mol, S. Repping, F. van der Veen, M. H. Mochtar

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Objective To study the effectiveness of four cycles of intrauterine insemination (IUI) with ovarian stimulation (OS) by follicle-stimulating hormone (FSH) or by clomiphene citrate (CC), and adherence to strict cancellation criteria. Setting Randomised controlled trial among 22 secondary and tertiary fertility clinics in the Netherlands. Participants 732 women from couples diagnosed with unexplained or mild male subfertility and an unfavourable prognosis according to the model of Hunault of natural conception. Interventions Four cycles of IUI-OS within a time horizon of 6 months comparing FSH 75 IU with CC 100 mg. The primary outcome is ongoing pregnancy conceived within 6 months after randomisation, defined as a positive heartbeat at 12 weeks of gestation. Secondary outcomes are cancellation rates, number of cycles with a monofollicular or with multifollicular growth, number of follicles > 14 mm at the time of ovulation triggering, time to ongoing pregnancy, clinical pregnancy, miscarriage, live birth and multiple pregnancy. We will also assess if biomarkers such as female age, body mass index, smoking status, antral follicle count and endometrial aspect and thickness can be used as treatment selection markers. Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on Research involving Human Subjects (CCMO NL 43131-018-13). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings

Original language	English
Pages (from-to)	e015680
Journal	BMJ Open
Volume	7
Issue number	5
DOIs	https://doi.org/10.1136/bmjopen-2016-015680
Publication status	Published - 2017

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https://doi.org/10.1136/bmjopen-2016-015680

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Danhof, N. A., van Wely, M., Koks, C. A. M., Gianotten, J., de Bruin, J. P., Cohlen, B. J., van der Ham, D. P., Klijn, N. F., van Hooff, M. H. A., Broekmans, F. J. M., Fleischer, K., Janssen, C. A. H., Rijn van Weert, J. M., van Disseldorp, J., Twisk, M., Traas, M., Verberg, M. F. G., Pelinck, M. J., Visser, J., ... Mochtar, M. H. (2017). The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination. BMJ Open, 7(5), e015680. https://doi.org/10.1136/bmjopen-2016-015680

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title = "The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination",

abstract = "Objective To study the effectiveness of four cycles of intrauterine insemination (IUI) with ovarian stimulation (OS) by follicle-stimulating hormone (FSH) or by clomiphene citrate (CC), and adherence to strict cancellation criteria. Setting Randomised controlled trial among 22 secondary and tertiary fertility clinics in the Netherlands. Participants 732 women from couples diagnosed with unexplained or mild male subfertility and an unfavourable prognosis according to the model of Hunault of natural conception. Interventions Four cycles of IUI-OS within a time horizon of 6 months comparing FSH 75 IU with CC 100 mg. The primary outcome is ongoing pregnancy conceived within 6 months after randomisation, defined as a positive heartbeat at 12 weeks of gestation. Secondary outcomes are cancellation rates, number of cycles with a monofollicular or with multifollicular growth, number of follicles > 14 mm at the time of ovulation triggering, time to ongoing pregnancy, clinical pregnancy, miscarriage, live birth and multiple pregnancy. We will also assess if biomarkers such as female age, body mass index, smoking status, antral follicle count and endometrial aspect and thickness can be used as treatment selection markers. Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on Research involving Human Subjects (CCMO NL 43131-018-13). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings",

author = "Danhof, {N. A.} and {van Wely}, M. and Koks, {C. A. M.} and J. Gianotten and {de Bruin}, {J. P.} and Cohlen, {B. J.} and {van der Ham}, {D. P.} and Klijn, {N. F.} and {van Hooff}, {M. H. A.} and Broekmans, {F. J. M.} and K. Fleischer and Janssen, {C. A. H.} and {Rijn van Weert}, {J. M.} and {van Disseldorp}, J. and M. Twisk and M. Traas and Verberg, {M. F. G.} and Pelinck, {M. J.} and J. Visser and Perquin, {D. A. M.} and Boks, {D. E. S.} and Verhoeve, {H. R.} and {van Heteren}, {C. F.} and Mol, {B. W. J.} and S. Repping and {van der Veen}, F. and Mochtar, {M. H.}",

year = "2017",

doi = "https://doi.org/10.1136/bmjopen-2016-015680",

language = "English",

volume = "7",

pages = "e015680",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "5",

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Danhof, NA, van Wely, M, Koks, CAM, Gianotten, J, de Bruin, JP, Cohlen, BJ, van der Ham, DP, Klijn, NF, van Hooff, MHA, Broekmans, FJM, Fleischer, K, Janssen, CAH, Rijn van Weert, JM, van Disseldorp, J, Twisk, M, Traas, M, Verberg, MFG, Pelinck, MJ, Visser, J, Perquin, DAM, Boks, DES, Verhoeve, HR, van Heteren, CF, Mol, BWJ , Repping, S , van der Veen, F & Mochtar, MH 2017, 'The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination', BMJ Open, vol. 7, no. 5, pp. e015680. https://doi.org/10.1136/bmjopen-2016-015680

TY - JOUR

T1 - The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination

AU - Danhof, N. A.

AU - van Wely, M.

AU - Koks, C. A. M.

AU - Gianotten, J.

AU - de Bruin, J. P.

AU - Cohlen, B. J.

AU - van der Ham, D. P.

AU - Klijn, N. F.

AU - van Hooff, M. H. A.

AU - Broekmans, F. J. M.

AU - Fleischer, K.

AU - Janssen, C. A. H.

AU - Rijn van Weert, J. M.

AU - van Disseldorp, J.

AU - Twisk, M.

AU - Traas, M.

AU - Verberg, M. F. G.

AU - Pelinck, M. J.

AU - Visser, J.

AU - Perquin, D. A. M.

AU - Boks, D. E. S.

AU - Verhoeve, H. R.

AU - van Heteren, C. F.

AU - Mol, B. W. J.

AU - Repping, S.

AU - van der Veen, F.

AU - Mochtar, M. H.

PY - 2017

Y1 - 2017

N2 - Objective To study the effectiveness of four cycles of intrauterine insemination (IUI) with ovarian stimulation (OS) by follicle-stimulating hormone (FSH) or by clomiphene citrate (CC), and adherence to strict cancellation criteria. Setting Randomised controlled trial among 22 secondary and tertiary fertility clinics in the Netherlands. Participants 732 women from couples diagnosed with unexplained or mild male subfertility and an unfavourable prognosis according to the model of Hunault of natural conception. Interventions Four cycles of IUI-OS within a time horizon of 6 months comparing FSH 75 IU with CC 100 mg. The primary outcome is ongoing pregnancy conceived within 6 months after randomisation, defined as a positive heartbeat at 12 weeks of gestation. Secondary outcomes are cancellation rates, number of cycles with a monofollicular or with multifollicular growth, number of follicles > 14 mm at the time of ovulation triggering, time to ongoing pregnancy, clinical pregnancy, miscarriage, live birth and multiple pregnancy. We will also assess if biomarkers such as female age, body mass index, smoking status, antral follicle count and endometrial aspect and thickness can be used as treatment selection markers. Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on Research involving Human Subjects (CCMO NL 43131-018-13). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings

AB - Objective To study the effectiveness of four cycles of intrauterine insemination (IUI) with ovarian stimulation (OS) by follicle-stimulating hormone (FSH) or by clomiphene citrate (CC), and adherence to strict cancellation criteria. Setting Randomised controlled trial among 22 secondary and tertiary fertility clinics in the Netherlands. Participants 732 women from couples diagnosed with unexplained or mild male subfertility and an unfavourable prognosis according to the model of Hunault of natural conception. Interventions Four cycles of IUI-OS within a time horizon of 6 months comparing FSH 75 IU with CC 100 mg. The primary outcome is ongoing pregnancy conceived within 6 months after randomisation, defined as a positive heartbeat at 12 weeks of gestation. Secondary outcomes are cancellation rates, number of cycles with a monofollicular or with multifollicular growth, number of follicles > 14 mm at the time of ovulation triggering, time to ongoing pregnancy, clinical pregnancy, miscarriage, live birth and multiple pregnancy. We will also assess if biomarkers such as female age, body mass index, smoking status, antral follicle count and endometrial aspect and thickness can be used as treatment selection markers. Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on Research involving Human Subjects (CCMO NL 43131-018-13). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings

U2 - https://doi.org/10.1136/bmjopen-2016-015680

DO - https://doi.org/10.1136/bmjopen-2016-015680

M3 - Article

C2 - 28550023

SN - 2044-6055

VL - 7

SP - e015680

JO - BMJ Open

JF - BMJ Open

IS - 5

ER -