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.
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.
Palomba
S
S
Unit of Reproductive Medicine and Surgery, Department of Obstetrics & Gynaecology, University Magna Graecia of Catanzaro, Viale Europa Catanzaro, Italy. stefanopalomba@tin.it
Falbo
A
A
Giallauria
F
F
Russo
T
T
Rocca
M
M
Tolino
A
A
Zullo
F
F
Orio
F
F
D000328:Adult; D002996:Clomiphene / Q000627:therapeutic use*; D004038:Diet, Reducing; D004351:Drug Resistance; D002149:Energy Intake; D015444:Exercise; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000628:therapy*; D008019:Life Style; D009765:Obesity / Q000150:complications / Q000188:drug therapy; D050177:Overweight; D010060:Ovulation / Q000187:drug effects; D010062:Ovulation Induction / Q000379:methods*; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000188:drug therapy*; D011247:Pregnancy
D002996:Clomiphene