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
Abstract
BACKGROUND: Clomiphene citrate (CC) is the first-line therapy for the induction of ovulation in infertile women with polycystic ovary syndrome (PCOS), but ∼20% of patients are unresponsive. The aim of the current study was to test the hypothesis that a 6-week intervention that consisted of structured exercise training (SET) and hypocaloric diet increases the probability of ovulation after CC in overweight and obese CC-resistant PCOS patients. METHODS: A cohort of 96 overweight and obese CC-resistant PCOS patients was enrolled consecutively in a three-arm randomized, parallel, controlled, assessor-blinded clinical trial. The three interventions were: SET plus hypocaloric diet for 6 weeks (Group A); 2 weeks of observation followed by one cycle of CC therapy (Group B); and SET plus hypocaloric diet for 6 weeks, with one cycle of CC after the first 2 weeks (Group C). The primary end-point was the ovulation rate. Other reproductive data, as well as anthropometric, hormonal and metabolic data, were also collected and considered as secondary end points. RESULTS: After 6 weeks of SET plus hypocaloric diet, the ovulation rate was significantly (P =0.008) higher in Group C [12/32 (37.5%)] than in Groups A [4/32 (12.5%)] and B [3/32 (9.4%)] with relative risks of 3.9 [95% confidence interval (CI) 1.1-8.3; P = 0.035] and 4.0 (95% CI 1.2-12.8; P = 0.020) compared with Groups A and B, respectively. Compared with baseline, in Groups A and C, a significant improvement in clinical and biochemical androgen and insulin sensitivity indexes was observed. In the same two groups, the insulin sensitivity index was significantly (P < 0.05) better than that in Group B. CONCLUSIONS: In overweight and obese CC-resistant PCOS patients, a 6-week intervention of SET and a hypocaloric diet was effective in increasing the probability of ovulation under CC treatment. The study was registered at Clinicaltrials.gov:NCT0100468.
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Lifestyle plus clomiphene citrate was better than lifestyle alone for ovulation rate and menstrual frequency in women with PCOS.
“Another study reported that lifestyle plus clomiphene citrate was better than lifestyle alone for ovulation rate and menstrual frequency ( P <0.05).”
From Assessment and management of polycystic ovary syndrome: Summary of an evidence-based guideline (2011) · cites this paper as [210]
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- Authors
- Palomba, S., Falbo, A., Giallauria, F., Russo, T., Rocca, M., Tolino, A., Zullo, F., & Orio, F.
- Affiliations
- Magna Graecia University (IT)
- Federico II University Hospital (IT)
- Parthenope University of Naples (IT)
- Corresponding author
- Palomba, S.
- Venue
- Human Reproduction
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-09-21
- Volume
- 25
- Issue
- 11
- Pages
- 2783-2791
- ISSN
- 0268-1161 (ISSN-L)
- 1460-2350
- OpenAlex
- W2127434314
- Cited by
- 111
- References
- 43
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 9 · 2023: 6 · 2022: 6 · 2021: 7 · 2020: 5 · 2019: 7 · 2018: 3 · 2017: 10 · 2016: 6 · 2015: 6 · 2014: 11 · 2013: 10 · 2012: 13
- FWCI
- 10.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Human Reproduction (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- CINECA IRIS Institutial research information system (Parthenope University of Naples) (submittedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Reproductive Medicine › Reproductive Health and Technologies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- polycystic ovary syndrome, clomiphene citrate resistance, ovulation induction, hypocaloric diet, obesity, overweight women, insulin sensitivity, androgen levels, infertility
- MeSH terms
- Adult, Energy Intake, Clomiphene, Diet, Reducing, Drug Resistance, Female, Humans, Infertility, Female, Life Style, Obesity, Ovulation, Ovulation Induction, Polycystic Ovary Syndrome, Pregnancy, Exercise, Overweight
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