Infertility, Obesity, Stable BMI
Conditions
Keywords
SET, infertility, IVF/ICSI, pregnancy
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.
Interventions
OTHERStructured exercise program.
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pregnancy rate. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| multiple pregnancy rate | 4 months |
| OHSS rate | 1 month |
| embryo transferred | 1 month |
| implantation rate | 1 month |
| stimulation lenght and dose | 1 month |
| cancellation rate | 1 months |
| miscarriage rate | 4 months |
Countries
Italy
Contacts
Primary ContactStefano Palomba, MD
Outcome results
None listed