Keywords: Infertility , Obesity , polycystic ovarian syndrome , emotionally focused therapy , weight loss
IRB Number: 00062463
Specialty: Reproductive Endocrinology and Infertility
Hypothesis: The addition of Emotionally Focused couples Therapy (EFT) to lifestyle change in women with obesity and anovulation will improve weight loss, address psychological needs (depression, attachment injury and health trauma) and improve fertility in obesity-related infertility. We posit that the novel features in this proposal will increase behavioral self-efficacy through enhancing mood and the family support system compared to lifestyle interventions alone, and synergistically improve fertility by simultaneously addressing male and female physical and psychological challenges: depression, attachment injury, and health trauma.
The primary outcome will be assessed upon completion of six months of weight loss for the female partner. Additional outcome measures will include changes in weight in both partners, and change in quality of life, mood, and couples attachment over the course of the study. If effectiveness trends are observed, results from this pilot study will be used to design a larger randomized trial comparing medically supervised weight loss with and without EFT to standard clinical weight loss counseling. While this pilot study is designed to detect weight loss and assess enrollment feasibility, a larger study will be powered to detect improved fertility and pregnancy outcomes.
Aim #1: In this pilot feasibility study, demonstrate the effectiveness of a couples multidisciplinary lifestyle support program, including supervised medical weight loss and emotionally focused couples therapy (EFT), in aiding weight loss in overweight, infertile women with obesity and anovulation and their overweight or obese partners.
Aim #2: In future study, demonstrate improvements in ovulatory frequency, sperm count, sperm DNA fragmentation, spontaneous conception rate, responsiveness to ovulation induction, impaired fasting glucose, systemic inflammation, fertility-related quality of life, depression, couples bonding, multiple pregnancies, preterm delivery, gestational diabetes, hypertensive disorders of pregnancy, NICU admission rate and cost per live birth following a couples multidisciplinary lifestyle support program.