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

NCT ID: NCT01952795

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-04-30

Brief Summary

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

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diet and exercise

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.

Group Type: ACTIVE_COMPARATOR

Diet and exercise

Intervention Type: 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.

No intervention

Usual diet and exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diet and exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan José Espinós-Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-DHE-2011-42

Identifier Type: -

Identifier Source: org_study_id