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Physical Activity and ARTs (SETART)

Primary Purpose

Infertility, Obesity, Stable BMI

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Structured exercise program.
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring SET, infertility, IVF/ICSI, pregnancy

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

structured exercise program (SET)

no intervention

Arm Description

SET one month before and during ARTs. IVF/ICSI procedure.

IVF/ICSI procedure.

Outcomes

Primary Outcome Measures

pregnancy rate.

Secondary Outcome Measures

stimulation lenght and dose
cancellation rate
implantation rate
OHSS rate
embryo transferred
miscarriage rate
multiple pregnancy rate

Full Information

First Posted
June 28, 2013
Last Updated
June 28, 2013
Sponsor
University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT01892111
Brief Title
Physical Activity and ARTs
Acronym
SETART
Official Title
Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Obesity, Stable BMI
Keywords
SET, infertility, IVF/ICSI, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
structured exercise program (SET)
Arm Type
Experimental
Arm Description
SET one month before and during ARTs. IVF/ICSI procedure.
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
IVF/ICSI procedure.
Intervention Type
Other
Intervention Name(s)
Structured exercise program.
Primary Outcome Measure Information:
Title
pregnancy rate.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
stimulation lenght and dose
Time Frame
1 month
Title
cancellation rate
Time Frame
1 months
Title
implantation rate
Time Frame
1 month
Title
OHSS rate
Time Frame
1 month
Title
embryo transferred
Time Frame
1 month
Title
miscarriage rate
Time Frame
4 months
Title
multiple pregnancy rate
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Palomba, MD
Email
stefanopalomba@tin.it
Facility Information:
Facility Name
Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Email
stefanopalomba@tin.it
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
First Name & Middle Initial & Last Name & Degree
Angela Falbo, MD
First Name & Middle Initial & Last Name & Degree
Giovanni B La Sala, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20858697
Citation
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.
Results Reference
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PubMed Identifier
18158291
Citation
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.
Results Reference
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Physical Activity and ARTs

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