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Randomized Controlled Trial
. 2017 May 25;7(5):e015680.
doi: 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  1 , M van Wely  1 , C A M Koks  2 , J Gianotten  3 , J P de Bruin  4 , B J Cohlen  5 , D P van der Ham  6 , N F Klijn  7 , M H A van Hooff  8 , F J M Broekmans  9 , K Fleischer  10 , C A H Janssen  11 , J M Rijn van Weert  12 , J van Disseldorp  13 , M Twisk  14 , M Traas  15 , M F G Verberg  16 , M J Pelinck  17 , J Visser  18 , D A M Perquin  19 , D E S Boks  20 , H R Verhoeve  21 , C F van Heteren  22 , B W J Mol  23 , S Repping  1 , F van der Veen  1 , M H Mochtar  1
Affiliations
Randomized Controlled Trial

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 et al. BMJ Open. .

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.

Keywords: Unexplained subfertility; clomiphene citrate; follicle stimulating hormone; intra uterine insemination; mild male factor subfertility; ovarian stimulation.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flowchart of study. CC, clomiphene citrate; FSH, follicle-stimulating hormone; ICI, intracervical insemination; IUI, intrauterine insemination; OS, ovarian stimulation; TMSC, total motile sperm count.
See this image and copyright information in PMC

References

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