Physical Activity and ARTs

Obesity Clinical Trial

— SETART  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01892111
• Other study ID #: 1/2013
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 28, 2013
• Last updated: June 28, 2013
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2013
• Source: University of Modena and Reggio Emilia
• Contact: Stefano Palomba, MD
• Email: stefanopalomba[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Obesity
• Stable BMI

Intervention

Other:
• Structured exercise program.

Locations

Country	Name	City	State
Italy	Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21. — View Citation

Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. Epub 2007 Dec 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate.		4 months	No
Secondary	stimulation lenght and dose		1 month	No
Secondary	cancellation rate		1 months	No
Secondary	implantation rate		1 month	No
Secondary	OHSS rate		1 month	Yes
Secondary	embryo transferred		1 month	No
Secondary	miscarriage rate		4 months	No
Secondary	multiple pregnancy rate		4 months	No