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Physical Activity and ARTs (SETART)

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ClinicalTrials.gov Identifier: NCT01892111
Recruitment Status : Unknown
Verified June 2013 by Stefano Palomba, University of Modena and Reggio Emilia.
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University of Modena and Reggio Emilia

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility Obesity Stable BMI Other: Structured exercise program. Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
Study Start Date : October 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy rate. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. stimulation lenght and dose [ Time Frame: 1 month ]
  2. cancellation rate [ Time Frame: 1 months ]
  3. implantation rate [ Time Frame: 1 month ]
  4. OHSS rate [ Time Frame: 1 month ]
  5. embryo transferred [ Time Frame: 1 month ]
  6. miscarriage rate [ Time Frame: 4 months ]
  7. multiple pregnancy rate [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892111


Contacts
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Contact: Stefano Palomba, MD stefanopalomba@tin.it

Locations
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Italy
Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia
Reggio Emilia, Italy, 42123
Contact: Stefano Palomba, MD       stefanopalomba@tin.it   
Principal Investigator: Stefano Palomba, MD         
Sub-Investigator: Angela Falbo, MD         
Principal Investigator: Giovanni B La Sala, MD         
Sponsors and Collaborators
University of Modena and Reggio Emilia
More Information
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Publications:

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Responsible Party: Stefano Palomba, Associate Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01892111    
Other Study ID Numbers: 1/2013
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: June 2013
Keywords provided by Stefano Palomba, University of Modena and Reggio Emilia:
SET
infertility
IVF/ICSI
pregnancy
Additional relevant MeSH terms:
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Infertility