Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- University of Modena and Reggio Emilia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- pregnancy rate.
- Last Updated
- 12 years ago
Overview
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.
Investigators
Stefano Palomba
Associate Professor
University of Modena and Reggio Emilia
Eligibility Criteria
Inclusion Criteria
- •infertility
- •stable BMI
- •schedule for ARTs
Exclusion Criteria
- •use of cryopreserved embryos
- •any changes in diet and physical activity
- •tobacco smoking
- •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
Outcomes
Primary Outcomes
pregnancy rate.
Time Frame: 4 months
Secondary Outcomes
- stimulation lenght and dose(1 month)
- embryo transferred(1 month)
- multiple pregnancy rate(4 months)
- implantation rate(1 month)
- cancellation rate(1 months)
- OHSS rate(1 month)
- miscarriage rate(4 months)