Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet and exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who want pregnancy. Basal FSH levels ≤ 10 IU / l. Infertility to justify treatment with IVF/ICSI. Being included in a long protocol with GnRH agonist. Presence of both ovaries and uterus able to support embryo implantation and pregnancy. Body mass index (BMI) ≥ 30 kg/m2 and ≤ 35 kg/m2. Absence of pregnancy before starting ovarian stimulation. Having given their written consent. Exclusion Criteria: Female age ≤ 18 years and ≥ 35 years. Severe male factor not permit an IVF-ICSI with ejaculated sample. Patients with low ovarian reserve (basal FSH levels ≥ 10 IU / l or lower antral follicle count to 6 follicles in both ovaries). HIV seropositivity, HBV or HCV. Clinically important disease. Having frozen embryos from previous cycles of assisted reproduction. Unexplained vaginal bleeding. Poor response in previous IVF cycles with standard stimulation protocols Any contraindication to become pregnant. Known allergy to preparations of gonadotropins or its excipients. High consumption of alcohol, drugs or psychotropic drugs. Concurrent participation in another study. Patients who have done previous cycles of IVF / ICSI without success

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet and exercise<br>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. | Behavioral: Diet and exercise<br>* 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.<br>|
| No Intervention: No intervention<br>Usual diet and exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Pregnancy rate by cycle | 14 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |