Clinical trial NCT01952795: Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
Official title: Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2013-09-30
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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/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

Primary outcomes:
measure: Pregnancy rate
timeFrame: 14 days after embryo transfer
Secondary outcomes:
measure: Hyperstimulation rate
timeFrame: At luteal phase and first weeks of pregnancy
measure: Fertility rate
timeFrame: 24 hours post pick up
measure: Mature oocytes
timeFrame: Pick up day
measure: Cancellation rate
timeFrame: Durinf the stimulation in follicular phase
measure: Good quality embryos
timeFrame: Day 3 to 5 post pick up
measure: Abortion rate
timeFrame: First trimester of pregnancy
measure: Live birth rate
timeFrame: Between 7 a 9 months after treatment
Other outcomes:
measure: Leptin, adiponectin, resistin, interleukin VI, TNF-α, visfatin, IGF1 and PAI I
timeFrame: During the stimulation phase
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Juan José Espinós-Gómez, MD
role: PRINCIPAL_INVESTIGATOR
References: