SUMMER-study
- Conditions
- Infertility, subfertility, male infertility, nutritional supplements
- Registration Number
- NL-OMON26205
- Lead Sponsor
- Radboud University Medical CentreDepartment of Obstetrics and GynaecologyPO Box 9101 6500HB NijmegenThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1200
Inclusion Criteria
Couples with failure to conceive for at least 12 months
Couples starting with EM or 1st/ 2nd/3rd cycle of IUI (with/without ovarian stimulation) or IVF/ICSI
Exclusion Criteria
Planned or performed diagnostic testicular biopsy (TESE) or percutaneous epididymal sperm aspiration (PESA)
Ovulation induction (OI) without IUI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test the hypothesis that the number of ongoing pregnancies (i.e. ≥12 weeks of gestation) will be improved by 7.5% in couples treated with Impryl® for infertility (IUI, IVF/ICSI or EM setting).
- Secondary Outcome Measures
Name Time Method Overall pregnancy rate. Time to pregnancy defined as both the time between a) start of intervention and reaching ongoing pregnancy, and as b) start of fertility treatment and reaching ongoing pregnancy. Change in semen parameters between baseline and 3 months intervention, based on pre-wash total motile sperm count (TMSC) from the subpopulation from Radboudumc and sites that deliver a pre-wash TMSC before IUI/IVF/ICSI. Number of miscarriages defined as a non-vital intra-uterine pregnancy before 16 weeks of gestation. Number of ongoing pregnancies above ≥ 20 weeks. Live birth rate defined as beyond 24 weeks of gestation, the birth of a living child. Live births will be reported within follow-up time of 15 months. Furthermore the following adverse events will be reported: gastro-intestinal problems such as reflux, obstipation, diarrhea, nausea or vomiting, furthermore loss of appetite, headache, dizziness, pruritus or skin rash.