Physical Activity and ARTs (SETART)

June 28, 2013 updated by: Stefano Palomba, University of Modena and Reggio Emilia

Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial

Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction.

In a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.

The aim of this randomized controlled trial (RCT) will be to evaluate if a structured exercise program improve the effectiveness of ARTs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women with primary infertility scheduled to an IVF/ICSI procedure, obese and with a stable BMI will be randomized to receive a structured exercise program or nothing.

Patients will undergo a gonadotropin ovarian hyperstimulation for standard IVF/ICSI procedure.

clinical and biological data will be evaluated in each subject.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy, 42123
        • Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertility
  • obesity
  • stable BMI
  • schedule for ARTs

Exclusion Criteria:

  • use of cryopreserved embryos
  • any changes in diet and physical activity
  • tobacco smoking
  • drug use
  • alcohol abuse
  • uterine diseases
  • previous pelvic surgery
  • major medical diseases
  • clinical history of (or suspicion of) endometriosis, antiphospholipid antibody syndrome, recurrent miscarriage
  • obese partner
  • severe sperm pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: structured exercise program (SET)
SET one month before and during ARTs. IVF/ICSI procedure.
Other: Structured exercise program.
NO_INTERVENTION: no intervention
IVF/ICSI procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: 1 month
1 month
stimulation lenght and dose
Time Frame: 1 month
1 month
cancellation rate
Time Frame: 1 months
1 months
OHSS rate
Time Frame: 1 month
1 month
embryo transferred
Time Frame: 1 month
1 month
miscarriage rate
Time Frame: 4 months
4 months
multiple pregnancy rate
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (ESTIMATE)

July 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 3, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Structured exercise program.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe