Feasibility of a brief, intensive weight loss intervention to improve reproductive outcomes in obese, subfertile women: a pilot study

Abstract

Objective To evaluate the feasibility of a brief, intensive weight loss intervention (IWL) to improve reproductive outcomes in obese subfertile women. Design Pilot study of IWL versus standard-of-care nutrition counseling (SCN) Setting Single-site, academic institution Patients Obese women (BMI 35 – 45 kg/m2) with anovulatory subfertility. Interventions Women were rigorously pre-screened to rule out secondary causes of subfertility. Eligible women were randomized to IWL or SCN. IWL consisted of 12 weeks of very-low energy diet (800 kcal/day) + 4 weeks of a low-calorie conventional food-based diet (CFD) to promote 15% weight loss. SCN consisted of 16 weeks of CFD to promote ≥ 5% weight loss. Women were transitioned to weight maintenance diets and referred back to reproductive endocrinology for ovulation induction. Main Outcome Measures Feasibility of recruitment, randomization, intervention implementation, and retention. Results Thirty-nine women were screened, 25 (64%) were eligible to participate, and 14 of those eligible (56%) agreed to be randomized - 7 in each group. One withdrew from the IWL group and 2 from the SCN group. Percent weight loss was greater in the IWL group than in the SCN group (13±5% vs. 4±4%) (p=0.01). Three of six women in the IWL group conceived and delivered term pregnancies. No pregnancies occurred in the SCN group. Conclusions After rigorous screening, 44% of eligible women completed the study. IWL was associated with greater percentage weight loss and improvements in insulin sensitivity. Trial Registration ClinicalTrials.gov NCT01894074

Health consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial

“…This would include 20% drop-out during the weight loss phase. The anticipated drop-out rate is based on pilot data, on previous studies conducted by Purcell [ 34 ] and Rothberg [ 61 ], and by the lifestyle interventional study conducted by Mutsaerts [ 17 ]. We anticipate a further 25% of participants will fail to become pregnant within 12 months or will experience an early pregnancy loss at < 20 weeks’ gestation.…”

Female infertility: which role for obesity?

“…The beneficial effect of bariatric surgery on anovulatory infertility was demostrated in a survey study of 195 anovulatory obese women who regained ovulation in 71% of cases after surgery [81]. However, a recently performed pilot study demonstrated that a brief intensive weight loss intervention in subfertile women with severe obesity resulted in improvement in ovulation similarly to bariatric surgery [82]. More studies are warranted to corroborate these interesting results.…”

The effectiveness of weight‐loss lifestyle interventions for improving fertility in women and men with overweight or obesity and infertility: A systematic review update of evidence from randomized controlled trials

“…The updated search identified eight new studies 44,45,48–53 . These eight RCTs, combined with the seven identified in our previous review 41,54–59 resulted in a total of 15 studies eligible for inclusion in the update.…”