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

NCT01952795 | Completed DMC

• 1 other identifier: IIBSP-DHE-2011-42
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Pregnancy rate by cycle

  14 days after embryo transfer

Secondary Outcomes (7)

• Hyperstimulation rate

  At luteal phase and first weeks of pregnancy

• Fertility rate

  24 hours post pick up

• Mature oocytes

  Pick up day

• Cancellation rate

  Durinf the stimulation in follicular phase

• Good quality embryos

  Day 3 to 5 post pick up

Other Outcomes (1)

• Leptin, adiponectin, resistin, interleukin VI, TNF-α, visfatin, IGF1 and PAI I

  During the stimulation phase

Study Arms (2)

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.

Behavioral: Diet and exercise

No intervention

NO INTERVENTION

Usual diet and exercise

Interventions

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.

Diet and exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan José Espinós-Gómez, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 30, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

ES (1)