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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet and exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
No Intervention: No intervention; Usual diet and exercise

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Fondo de Investigacion Sanitaria
• Investigators: Principal Investigator: Juan José Espinós-Gómez, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimate): September 30, 2013

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IIBSP-DHE-2011-42