SUMMER-study

The impact of a nutritional supplement (Impryl®) on male fertility

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26205

Enrollment

1200

Registered

2017-06-15

Start date

2017-10-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, subfertility, male infertility, nutritional supplements

Interventions

nutritional supplement Impryl®

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactR.M. Smits

Department: Afdeling Verloskunde en Gynaecologie, Pijler Voortplantingsgeneeskunde

SUMMERstudie.verlgyn@radboudumc.nl06 51751244

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)