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 & 7 others D. 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 journalArticle

2 Citations (Scopus)

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.

LanguageEnglish
Article numbere015680
JournalBMJ open
Volume7
Issue number5
DOIs
Publication statusPublished - 1 May 2017

Keywords

  • Unexplained subfertility
  • clomiphene citrate
  • follicle stimulating hormone
  • intra uterine insemination
  • mild male factor subfertility
  • ovarian stimulation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. ; Perquin, D. A.M. ; Boks, D. E.S. ; Verhoeve, H. R. ; Van Heteren, C. F. ; Mol, B. W.J. ; Repping, S. ; Van Der Veen, F. ; Mochtar, M. H. / The SUPER study : Protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination. In: BMJ open. 2017 ; Vol. 7, No. 5.
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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.",
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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, e015680. 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. / 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.; Perquin, D. A.M.; Boks, D. E.S.; Verhoeve, H. R.; Van Heteren, C. F.; Mol, B. W.J.; Repping, S.; Van Der Veen, F.; Mochtar, M. H.

In: BMJ open, Vol. 7, No. 5, e015680, 01.05.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The SUPER study

T2 - BMJ Open

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 - 2017/5/1

Y1 - 2017/5/1

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.

KW - Unexplained subfertility

KW - clomiphene citrate

KW - follicle stimulating hormone

KW - intra uterine insemination

KW - mild male factor subfertility

KW - ovarian stimulation

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U2 - 10.1136/bmjopen-2016-015680

DO - 10.1136/bmjopen-2016-015680

M3 - Article

VL - 7

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

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M1 - e015680

ER -