Physical Activity and ARTs (SETART)

University of Modena and Reggio Emilia

Status and phase: Unknown; Phase 4

Conditions: Infertility; Stable BMI; Obesity

Treatments: Other: Structured exercise program.

Study type: Interventional

Funder types: Other

Identifiers

NCT01892111

1/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

structured exercise program (SET)

Experimental group

Description:

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

Treatment:

Other: Structured exercise program.

no intervention

No Intervention group

Description:

IVF/ICSI procedure.