You are here

  • Home
  • Archive
  • Volume 7, Issue 5
  • The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination

Article Text

Article menu

Download PDFPDF

XML
Reproductive medicine
Protocol
The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination
  1. NA Danhof1,
  2. M van Wely1,
  3. CAM Koks2,
  4. J Gianotten3,
  5. JP de Bruin4,
  6. BJ Cohlen5,
  7. DP van der Ham6,
  8. NF Klijn7,
  9. MHA van Hooff8,
  10. FJM Broekmans9,
  11. K Fleischer10,
  12. CAH Janssen11,
  13. JM Rijn van Weert12,
  14. J van Disseldorp13,
  15. M Twisk14,
  16. M Traas15,
  17. MFG Verberg16,
  18. MJ Pelinck17,
  19. J Visser18,
  20. DAM Perquin19,
  21. DES Boks20,
  22. HR Verhoeve21,
  23. CF van Heteren22,
  24. BWJ Mol23,
  25. S Repping1,
  26. F van der Veen1,
  27. MH Mochtar1
  1. 1 Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands
  2. 2 Obstetrics and gynaecology, Maxima Medical Center, Veldhoven, The Netherlands
  3. 3 Kennemer Hospital, Haarlem, The Netherlands
  4. 4 Jeroen Bosch Hospital, Den Bosch, The Netherlands
  5. 5 Isala Zwolle, Zwolle, The Netherlands
  6. 6 Martini Hospital, Groningen, The Netherlands
  7. 7 Leiden University Medical Centre, Leiden, The Netherlands
  8. 8 Sint Franciscus Gasthuis, Rotterdam, The Netherlands
  9. 9 Reproductive Medicine, UMC Utrecht, Utrecht, The Netherlands
  10. 10 Radboud University Medical Centre, Nijmegen, The Netherlands
  11. 11 Groene Hart Hospital, Gouda, The Netherlands
  12. 12 NoordWest Groep Alkmaar, Alkmaar, The Netherlands
  13. 13 St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands
  14. 14 MC Zuiderzee, Lelystad, The Netherlands
  15. 15 Gelre Hospital, Apeldoorn, The Netherlands
  16. 16 Fertility Clinic Twente, Twente, The Netherlands
  17. 17 Scheper Hospital, Emmen, The Netherlands
  18. 18 Amphia, Breda, The Netherlands
  19. 19 Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  20. 20 Spaarne Hospital, Hoofddorp, The Netherlands
  21. 21 OLVG, Amsterdam, The Netherlands
  22. 22 Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
  23. 23 The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelade, Adelaide, Australia
  1. Correspondence to Ms. NA Danhof; n.a.danhof{at}amc.uva.nl

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.

Trial registration number NTR4057.

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

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors ND is responsible for the overall logistical aspects of the trial and drafted the paper. MHM, FvdV and MvW designed the trial and were responsible for the development of the protocol. ND, CK, JG, JPdB, BJC, DPvdH, NFK, MHAvH, FB, KF, CAHJ, JMRvW, JvD, M Twisk, M Traas, MFGV, MJP, JV, DAMP, DESB, HRV, CFvH, BWJM, SR, MHM and MvW contributed to the protocol included patients and approved the final version of the paper.

    • Competing interests None declared.

    • Ethics approval Approved by METC AMC Amsterdam.

    • Provenance and peer review Not commissioned; externally peer reviewed.