Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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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.
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Detailed Description
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Patients will undergo a gonadotropin ovarian hyperstimulation for standard IVF/ICSI procedure.
clinical and biological data will be evaluated in each subject.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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structured exercise program (SET)
SET one month before and during ARTs. IVF/ICSI procedure.
Structured exercise program.
no intervention
IVF/ICSI procedure.
No interventions assigned to this group
Interventions
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Structured exercise program.
Eligibility Criteria
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Inclusion Criteria
* obesity
* stable BMI
* schedule for ARTs
Exclusion Criteria
* 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
18 Years
42 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Stefano Palomba
Associate Professor
Locations
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Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
Other Identifiers
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1/2013
Identifier Type: -
Identifier Source: org_study_id
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