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Completed

NCT Number: NCT01952795

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet and Exercise

Behavioral

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.

Primary outcomes

  1. Pregnancy rate

    Time frame: 14 days after embryo transfer

    Pregnancy rate by cycle

Secondary outcomes

  1. Hyperstimulation rate

    Time frame: At luteal phase and first weeks of pregnancy

    Number of patients with moderate or severe hyperstimulation

  2. Fertility rate

    Time frame: 24 hours post pick up

    Rate of mature oocytes fertilized by conventional IVF or ICSI

  3. Mature oocytes

    Time frame: Pick up day

    Number of total mature oocytes obtained after stimulation

  4. Cancellation rate

    Time frame: Durinf the stimulation in follicular phase

    Stimulated Patients who fail to perform the follicular puncture

  5. Good quality embryos

    Time frame: Day 3 to 5 post pick up

    Number of good quality embryos obtained (A and B) by patient

  6. Abortion rate

    Time frame: First trimester of pregnancy

    Number of non evolutive pregnancies during the first trimester

  7. Live birth rate

    Time frame: Between 7 a 9 months after treatment

    Amount of patients who finish the treatment with a live newborn

Other outcomes

  1. Leptin, adiponectin, resistin, interleukin VI, TNF-α, visfatin, IGF1 and PAI I

    Time frame: During the stimulation phase

    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.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 30, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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