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SUPER

 

Superovulation in intra uterine insemination: FSH or clomifene citrate?

 

 

Go to the SUPER website

 

Background
In The Netherlands, the first line treatment for patients diagnosed with unexplained
subfertility or mild male factor is intrauterine insemination with ovarian stimulation. Ovarian stimulation can be achieved with follicle stimulating hormone (FSH) or with Clomifene citrate (CC). Through ovarian superstimulation multiple follicles are recruited, which increases pregnancy chances.

 

A Cochrane meta-analysis pooling the evidence of 7 studies including 566 subfertile couples suggests a favor for FSH compared to CC and most clinics in The Netherlands use FSH. The downside of the use of ovarian superstimulation is the increased risk of multiple pregnancies. In an effort to reduce multiple pregnancy rates but maintain an acceptable pregnancy rate at the same time, one aims to recruit only two dominant follicles.
Only one study comparing FSH to clomifene citrate while aiming to recruit two follicles and showed equal pregnancy results. This study however was underpowered and the vast majority of Dutch clinics continue to stimulate with FSH, resulting in an annual cost of 11 million euro for medication costs alone.

 

Objective
To determine which ovarian superstimulation regimen (FSH or CC) aiming to recruit only two dominant follicles should be applied in IUI in couples with unexplained subfertility or mild male factor subfertility.

 

Study design
Nationwide parallel multicenter randomised clinical trial,comparing FSH with CC as ovarian stimulation in IUI and an economic analysis alongside it.

 

Time schedule
A total of 48 months will be needed; 3 months preparation, 32 months inclusion, 6 months treatment, 3 months follow up until establishing an ongoing pregnancy and 4 months analysis/report writing.

 

Study population
Women diagnosed with unexplained or mild male factor subfertility according to Dutch guidelines and an unfavourable prognosis according to the model of Hunault on the occurrence of a spontaneous pregnancy within one year.

 

Intervention
A maximum of 4 cycles of IUI with ovarian stimulation. In the first cycle one group receives daily 75 IU FSH subcutaneously form cycle day 3 until ovulation triggering, The other group receives oral tablets Clomifene Citrate 100 mg daily from cycle day 3 until cycle day 7. The next cycles, dosages may be adjusted appropriately. The time horizon will be 6 months.

 

Main study parameters/endpoints
Primary outcome is ongoing pregnancy rate defined as a positive heartbeat at 12 weeks gestation determined by transvaginal ultrasound.
Secondary endpoints are multiple pregnancy rates, miscarriage rate, live birth rate and patients' preference and costs.

 

Nature and extent of the burden and risks associated with participation, benefit and
group relatedness
The strategies compared are already broadly applied in current practice. No additional risks are expected. Patients will be asked to fill in a questionnaire to compare the severity of the already know side effects of both medications. There is no benefit for participants, but the results may benefit future subfertile couples.

 

Projectleaders
dr. M.H. Mochtar
Dept. Obstetrics/Gynaecology
AMC Amsterdam
E: m.h.mochtar@amc.uva.nl

 

Methodology
dr. M. van Wely
Dept. Obstetrics/Gynaecology
AMC Amsterdam
E: m.vanwely@amc.uva.nl

 

Subsidy
ZonMW

 

Contact (researcher)
N.A. Danhof
PhD student
Centre for Reproductive Medicine
Academic Medical Centre, the Netherlands
E. n.a.danhof@amc.uva.nl
T: +31 20 5669111 pager 58324 / +31 6 45422112