Physical Activity and ARTs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Obesity, Stable BMI

Intervention / Treatment
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* Other: Structured exercise program.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: structured exercise program (SET)<br>SET one month before and during ARTs. IVF/ICSI procedure. | Other: Structured exercise program.<br> <br> |
| No Intervention: no intervention<br>IVF/ICSI procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate. |  | 4 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SET, infertility, IVF/ICSI, pregnancy