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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.
Afiliação
  • Danhof NA; Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.
  • van Wely M; Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.
  • Koks CAM; Obstetrics and gynaecology, Maxima Medical Center, Veldhoven, The Netherlands.
  • Gianotten J; Kennemer Hospital, Haarlem, The Netherlands.
  • de Bruin JP; Jeroen Bosch Hospital, Den Bosch, The Netherlands.
  • Cohlen BJ; Isala Zwolle, Zwolle, The Netherlands.
  • van der Ham DP; Martini Hospital, Groningen, The Netherlands.
  • Klijn NF; Leiden University Medical Centre, Leiden, The Netherlands.
  • van Hooff MHA; Sint Franciscus Gasthuis, Rotterdam, The Netherlands.
  • Broekmans FJM; Reproductive Medicine, UMC Utrecht, Utrecht, The Netherlands.
  • Fleischer K; Radboud University Medical Centre, Nijmegen, The Netherlands.
  • Janssen CAH; Groene Hart Hospital, Gouda, The Netherlands.
  • Rijn van Weert JM; NoordWest Groep Alkmaar, Alkmaar, The Netherlands.
  • van Disseldorp J; St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.
  • Twisk M; MC Zuiderzee, Lelystad, The Netherlands.
  • Traas M; Gelre Hospital, Apeldoorn, The Netherlands.
  • Verberg MFG; Fertility Clinic Twente, Twente, The Netherlands.
  • Pelinck MJ; Scheper Hospital, Emmen, The Netherlands.
  • Visser J; Amphia, Breda, The Netherlands.
  • Perquin DAM; Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
  • Boks DES; Spaarne Hospital, Hoofddorp, The Netherlands.
  • Verhoeve HR; OLVG, Amsterdam, The Netherlands.
  • van Heteren CF; Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
  • Mol BWJ; The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelade, Adelaide, Australia.
  • Repping S; Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.
  • van der Veen F; Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.
  • Mochtar MH; Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.
BMJ Open ; 7(5): e015680, 2017 05 25.
Article em En | MEDLINE | ID: mdl-28550023
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Indução da Ovulação / Clomifeno / Fármacos para a Fertilidade Feminina / Hormônio Foliculoestimulante / Infertilidade Feminina / Inseminação Artificial Homóloga Tipo de estudo: Clinical_trials / Prognostic_studies / Systematic_reviews Limite: Adult / Female / Humans / Pregnancy País/Região como assunto: Europa Idioma: En Revista: BMJ Open Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Holanda

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Indução da Ovulação / Clomifeno / Fármacos para a Fertilidade Feminina / Hormônio Foliculoestimulante / Infertilidade Feminina / Inseminação Artificial Homóloga Tipo de estudo: Clinical_trials / Prognostic_studies / Systematic_reviews Limite: Adult / Female / Humans / Pregnancy País/Região como assunto: Europa Idioma: En Revista: BMJ Open Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Holanda