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In this study, patients with infertility treated with IVF at the Center of Reproductive Medicine in Linköping, Sweden, will receive recipes and food according to Nordic dietary guidelines. The purpose is to investigate whether a short diet intervention is sufficient to improve sperm quality and shift the small non-coding RNA profile. In our previous study sperm showed rapid response to diet.
This study is a randomized controlled trial recruiting males seeking IVF treatment with their female partner at the Center for Reproductive Medicine in Linkoping, Sweden. Men will be randomized to a control group or diet intervention group.
The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure.
The male partner must accept to participate in the diet intervention in order to be included and the female partner can choose to participate in the diet intervention but it is optional. Sperm samples will be collected before the start of hormonal treatment and on ovum pick-up day. Weight will be measured before and after the intervention. Sperm samples will be processed as standard practice at the fertility clinic. Sperm samples will be used for molecular analysis, such as small RNA sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet intervention- Nordic nutrition recommendations | Active Comparator | The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure. |
|
| No diet intervention | No Intervention | No intervention - this group will only receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet intervention NMR | Dietary Supplement | Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm RNA profile changes | Small RNA profiling and sequencing will be performed on sperm cells provided by participant at the start of controlled ovarian hormone stimulation of partner and at time of ovum pick-up and compared between the intervention groups. | At day at ovum pick-up |
| Sperm total count | Sperm total count in millions, assessed by sperm analysis | At day of ovum pick-up |
| Sperm concentration | Sperm concentration assessed by sperm analysis in millions/ml, with total sperm count in millions, divided by semen volume assessed in ml. | At day of ovum pick-up |
| Sperm sample analysis | Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent | At day of ovum pick-up |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent) | Day one after ovum pick-up |
| High quality embryo rate | Number of high quality embryo in relation to total number of oocytes fertilised |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress in sperm sample | Reactive oxygen species analysis of semen | At day of ovum pick-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Liffner, M.D, Ph.D. | Contact | +46 (0)101030000 | susanne.liffner@liu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Linköping | Östergötland County | 58185 | Sweden |
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| Day 6 after ovum pick-up |
| Embryos frozen | Number of good quality embryos frozen | Day 5 and/or 6 after ovum pick-up |
| Clinical pregnancy rate | Defined by viable intra-uterine pregnancy at ultrasonography in gestational week 7-9 | Assessed 5-7 weeks after ovum pick-up |
| Pregnancy rate | Positive pregnancy test in urine (hCG) after IVF | Assessed three weeks after ovum pick-up |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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