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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952795
• Other study ID #: IIBSP-DHE-2011-42
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: August 21, 2017
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Leptin, adiponectin, resistin, interleukin VI, TNF-a, 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-a, visfatin, IGF1 and PAI I) or with inflammatory parameters results of an IVF cycle.	During the stimulation phase
Primary	Pregnancy rate	Pregnancy rate by cycle	14 days after embryo transfer
Secondary	Hyperstimulation rate	Number of patients with moderate or severe hyperstimulation	At luteal phase and first weeks of pregnancy
Secondary	Fertility rate	Rate of mature oocytes fertilized by conventional IVF or ICSI	24 hours post pick up
Secondary	Mature oocytes	Number of total mature oocytes obtained after stimulation	Pick up day
Secondary	Cancellation rate	Stimulated Patients who fail to perform the follicular puncture	Durinf the stimulation in follicular phase
Secondary	Good quality embryos	Number of good quality embryos obtained (A and B) by patient	Day 3 to 5 post pick up
Secondary	Abortion rate	Number of non evolutive pregnancies during the first trimester	First trimester of pregnancy
Secondary	Live birth rate	Amount of patients who finish the treatment with a live newborn	Between 7 a 9 months after treatment