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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Diet and exercise

• Registration Number: NCT01952795
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Study Start: 2013-11
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and exercise	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	14 days after embryo transfer	Pregnancy rate by cycle

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Between 7 a 9 months after treatment	Amount of patients who finish the treatment with a live newborn
Abortion rate	First trimester of pregnancy	Number of non evolutive pregnancies during the first trimester
Cancellation rate	Durinf the stimulation in follicular phase	Stimulated Patients who fail to perform the follicular puncture
Good quality embryos	Day 3 to 5 post pick up	Number of good quality embryos obtained (A and B) by patient
Hyperstimulation rate	At luteal phase and first weeks of pregnancy	Number of patients with moderate or severe hyperstimulation
Fertility rate	24 hours post pick up	Rate of mature oocytes fertilized by conventional IVF or ICSI
Mature oocytes	Pick up day	Number of total mature oocytes obtained after stimulation

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain