Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
NCT Number: NCT01952795
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.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Barcelona, 08025, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 days after embryo transfer
Pregnancy rate by cycle
Time frame: At luteal phase and first weeks of pregnancy
Number of patients with moderate or severe hyperstimulation
Time frame: 24 hours post pick up
Rate of mature oocytes fertilized by conventional IVF or ICSI
Time frame: Pick up day
Number of total mature oocytes obtained after stimulation
Time frame: Durinf the stimulation in follicular phase
Stimulated Patients who fail to perform the follicular puncture
Time frame: Day 3 to 5 post pick up
Number of good quality embryos obtained (A and B) by patient
Time frame: First trimester of pregnancy
Number of non evolutive pregnancies during the first trimester
Time frame: Between 7 a 9 months after treatment
Amount of patients who finish the treatment with a live newborn
Time frame: During the stimulation phase
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.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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