Physical Activity and ARTs

Phase 4

• Conditions: Stable BMI; Obesity; Infertility

• Registration Number: NCT01892111
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Last Update Submitted: 2013-06-28
• Study First Posted: 2013-07-03
• Last Update Posted: 2013-07-03
• Study Start: 2013-10
• Primary Completion: 2014-05
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pregnancy rate.	4 months

Secondary Outcome Measures

Name	Time	Method
implantation rate	1 month
cancellation rate	1 months
miscarriage rate	4 months
stimulation lenght and dose	1 month
embryo transferred	1 month
multiple pregnancy rate	4 months
OHSS rate	1 month

Trial Locations

Locations (1)

Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia; 🇮🇹 Reggio Emilia, Italy