Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Pregnancy rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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/m
- •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.
Outcomes
Primary Outcomes
Pregnancy rate
Time Frame: 14 days after embryo transfer
Pregnancy rate by cycle
Secondary Outcomes
- Abortion rate(First trimester of pregnancy)
- Cancellation rate(Durinf the stimulation in follicular phase)
- Hyperstimulation rate(At luteal phase and first weeks of pregnancy)
- Fertility rate(24 hours post pick up)
- Live birth rate(Between 7 a 9 months after treatment)
- Mature oocytes(Pick up day)
- Good quality embryos(Day 3 to 5 post pick up)