Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle.
The objective of this study is showing that obesity significantly affects the in vitro fertilization cycles lowering the reproductive capacity. The study is been performed in Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted are obese women with sterility problems that require in vitro fertilization (IVF) with a body mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo to a 6 weeks program of diet and exercice. We will analyse the response to ovaric stimulation, the results of the egg retrieval (ovocyte number and quality), rates of fecundation, embryo implantation and clinical gestation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet and exercise | Active Comparator | Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. 3 sessions per week on a bicycle ergometer or on a treadmill (according to body fat distribution and other parameters) modifications carried out weekly, with a gradual increase as to exercise until maximal oxygen consumption 60 - 70% would always preceded by heating 5 minutes. |
|
| No intervention | No Intervention | Usual diet and exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet and exercise | Behavioral | Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Pregnancy rate by cycle | 14 days after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperstimulation rate | Number of patients with moderate or severe hyperstimulation | At luteal phase and first weeks of pregnancy |
| Fertility rate | Rate of mature oocytes fertilized by conventional IVF or ICSI |
| Measure | Description | Time Frame |
|---|---|---|
| Leptin, adiponectin, resistin, interleukin VI, TNF-α, visfatin, IGF1 and PAI I | Study the relationship between obesity and measurable surrogate parameters the same as the products of secretion of fat (leptin, adiponectin, resistin, interleukin VI, TNF-α, visfatin, IGF1 and PAI I) or with inflammatory parameters results of an IVF cycle. | During the stimulation phase |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan José Espinós-Gómez, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 24 hours post pick up |
| Mature oocytes | Number of total mature oocytes obtained after stimulation | Pick up day |
| Cancellation rate | Stimulated Patients who fail to perform the follicular puncture | Durinf the stimulation in follicular phase |
| Good quality embryos | Number of good quality embryos obtained (A and B) by patient | Day 3 to 5 post pick up |
| Abortion rate | Number of non evolutive pregnancies during the first trimester | First trimester of pregnancy |
| Live birth rate | Amount of patients who finish the treatment with a live newborn | Between 7 a 9 months after treatment |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |