Clinical trial NCT01892111: Physical Activity and ARTs
Official title: Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Obesity
Stable BMI
Keywords: SET
infertility
IVF/ICSI
pregnancy
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pregnancy rate.
timeFrame: 4 months
Secondary outcomes:
measure: stimulation lenght and dose
timeFrame: 1 month
measure: cancellation rate
timeFrame: 1 months
measure: implantation rate
timeFrame: 1 month
measure: OHSS rate
timeFrame: 1 month
measure: embryo transferred
timeFrame: 1 month
measure: miscarriage rate
timeFrame: 4 months
measure: multiple pregnancy rate
timeFrame: 4 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia
Study officials:
References:
citation: 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.
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. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.