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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| structured exercise program (SET) | Experimental | SET one month before and during ARTs. IVF/ICSI procedure. |
|
| no intervention | No Intervention | IVF/ICSI procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured exercise program. | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| stimulation lenght and dose | 1 month | |
| cancellation rate | 1 months | |
| implantation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Palomba, MD | Contact | stefanopalomba@tin.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia | Reggio Emilia | 42123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20858697 | Background | 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. | |
| 18158291 |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| 1 month |
| OHSS rate | 1 month |
| embryo transferred | 1 month |
| miscarriage rate | 4 months |
| multiple pregnancy rate | 4 months |
| Background |
| 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |