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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Skane University Hospital | OTHER |
| Region Örebro County | OTHER |
| Rigshospitalet, Denmark |
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The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.
There will be two groups of patients.
Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF only | No Intervention | IVFtreatment | |
| Weight reduction treatment and IVF | Active Comparator | Dietary Supplement: Low calorie diet treatment and then IVFtreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low calorie diet treatment | Dietary Supplement | Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Live birth per participating woman | Approximately 10-16 months after randomization, depending on study group. |
| Measure | Description | Time Frame |
|---|---|---|
| embryology | number of good quality embryos | After theIVF-treatment, approximately 1-6 months after randomization |
| obstetric outcomes | obstetric and neonatal data |
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Inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Thurin Kjellberg, MD PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev hospital | Copenhagen | Denmark | ||||
| Hvidovre hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35922472 | Derived | Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2. | |
| 31844684 | Derived |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| OTHER |
| Hvidovre University Hospital | OTHER |
| Herlev Hospital | OTHER |
| Holbaek Sygehus | OTHER |
| ART Medica clinic, Iceland | UNKNOWN |
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| Approximately 10-16 months after randomization, after delivery |
| compliance to intervention | Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life | Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment |
| Husband data | Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation | before IVF-treatment |
| Copenhagen |
| Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Holbaek hospital | Holbæk | Denmark |
| ART Medica | Reykjavik | Iceland |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Skånes Universitetssjukhus | Malmö | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | Sweden |
| Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019. |
| 28854592 | Derived | Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |