|- candidate number||27405|
|- NTR Number||NTR6551|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-jun-2017|
|- Secondary IDs||NL61414.091.17 |
|- Public Title||SUMMER-study|
|- Scientific Title||The impact of a nutritional supplement (ImprylŪ) on male fertility |
|- hypothesis||To determine the effectiveness of nutritional supplement ImprylŪ on pregnancy rate in men of infertile couples, with or without medically assisted reproduction (MAR).|
|- Healt Condition(s) or Problem(s) studied||Infertility, Nutrition supplement|
|- 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
Male with age 18-50 years
Female partner with age 18-43 years
Willing and able to give informed consent
|- Exclusion criteria||Planned or performed diagnostic testicular biopsy (TESE) or percutaneous epididymal sperm aspiration (PESA)|
Ovulation induction (OI) without IUI
IVF for an absolute tubal factor
Embryo-transfers after cryopreservation
Known chromosomal abnormalities related to infertility
Known urological abnormality such as a varicocele
Use of other vitamin supplements
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2017|
|- planned closingdate||1-okt-2020|
|- Target number of participants||1200|
|- Interventions||nutritional supplement ImprylŪ|
|- Primary outcome||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 ImprylŪ for infertility (IUI, IVF/ICSI or EM setting). |
|- Secondary outcome||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.|
|- Timepoints||0 - 1 - 2 - 3 - 4 - 5 - 6 - 15 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. R.M. Smits|
|- CONTACT for SCIENTIFIC QUERIES||Drs. R.M. Smits|
|- Sponsor/Initiator ||Radboud University Medical Centre Department of Obstetrics and Gynaecology |
(Source(s) of Monetary or Material Support)
|Goodlife Fertility B.V.|
|- Brief summary||Rationale: Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples a male factor is involved. In the past decade, the role of oxidative stress on sperm has been researched thoroughly and found to be the problem in 30% to 80% of male infertility cases. ImprylŪ is a nutritional supplement which works on the metabolic system and regulation of oxidative stress by activating the one carbon cycle and therefore recycling of homocysteine.|
Objective: To determine the effectiveness of nutritional supplement ImprylŪ in men of infertile couples on ongoing pregnancy rate, with or without assisted reproduction technology (ART).
Study design: Multicentre, randomised double blind placebo controlled clinical trial/superiority study.
Study population: All participants in this study are male adults, age 18-50 years, part of a couple that is diagnosed with infertility, unregarded the outcome of semen analysis. The couple will either start or is already started with fertility treatment, i.e. expectative management (EM, duration 6 months), intra-uterine insemination (IUI) with or without ovarian stimulation (mild ovarian hyperstimulation (MOH) or ovulation induction (OI)), either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
Intervention: ImprylŪ or placebo, with identical appearance one tablet each day for a total duration of 6 months. Intervention has to be consumed for at least 3 consecutive months before using semen for ART. In case of expectative management, patients can start directly to conceive.
Main study parameters/endpoints: The primary outcome is the number of ongoing pregnancies ≥ 12 weeks. Secondary outcomes are change in semen parameters between baseline and 3 months intervention in IUI/IVF/ICSI group, based on (pre-wash) total motile sperm count (TMSC). Furthermore the occurrence of pregnancy, time to pregnancy, number of miscarriages, number of ongoing pregnancies ≥ 20 weeks and live birth rate are documented within the study period. The occurrence of adverse events will be reported.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Couples with infertility will receive standard fertility treatment, i.e. EM or ART. The risks and burden of participating in the trial are small. After a complete diagnostic work-up for infertility, the males will be randomised for use of either ImprylŪ or placebo. ImprylŪ is a food supplement already free available throughout Europe. Males need to take study medication one tablet each day for 6 months in total. For this study, we want to measure improvement of semen parameters after at least 3 months use of study medication. Performing a pre-wash TMSC is in Radboudumc standard procedure when semen is used for IUI or IVF/ICSI. However, at some sites there is only a post-wash TMSC available. Furthermore, in couples with EM performing a TMSC after 3 months is not standard care. We decided not to perform a semen analysis in the EM group due to the fact that improvement in fertility treatment from expectative management is not possible. Participants are required to collect study medication directly at their local hospital or at Radboudumc. At the start of taking study medication the couple is asked to fill in a questionnaire about their baseline characteristics. To asses lifestyle changes during intervention and amount of used study medication, every male will be asked each month (6 times in total) to fill in an online questionnaire. Every couple will receive a final questionnaire, 15 months after inclusion, about the outcome of fertility treatment and occurrence of pregnancy. If a women of a couple is pregnant there is one extra site visit to have an ultrasound at 12 weeks of pregnancy for determining the primary outcome. In conclusion, the burden and risks associated with participation in this trial can be considered negligible.
|- Main changes (audit trail)|
|- RECORD||15-jun-2017 - 22-okt-2017|