Physical Activity and ARTs (SETART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: structured exercise program (SET)
SET one month before and during ARTs. IVF/ICSI procedure.
Other: Structured exercise program.
No Intervention: no intervention
- pregnancy rate. [ Time Frame: 4 months ]
- stimulation lenght and dose [ Time Frame: 1 month ]
- cancellation rate [ Time Frame: 1 months ]
- implantation rate [ Time Frame: 1 month ]
- OHSS rate [ Time Frame: 1 month ]
- embryo transferred [ Time Frame: 1 month ]
- miscarriage rate [ Time Frame: 4 months ]
- multiple pregnancy rate [ Time Frame: 4 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 42 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- stable BMI
- schedule for ARTs
- 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
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
|Contact: Stefano Palomba, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Stefano Palomba, MD|
|Sub-Investigator: Angela Falbo, MD|
|Principal Investigator: Giovanni B La Sala, MD|
|Responsible Party:||Stefano Palomba, Associate Professor, University of Modena and Reggio Emilia|
|Other Study ID Numbers:||
|First Posted:||July 3, 2013 Key Record Dates|
|Last Update Posted:||July 3, 2013|
|Last Verified:||June 2013|