Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

PHASE3CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

November 30, 2019

Study Completion Date

May 31, 2020

Conditions
Infertility, Female
Interventions
OTHER

Caloric Restriction

Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

DRUG

Orlistat

Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

OTHER

Moderate physical activity

All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Trial Locations (10)

14642

University of Rochester, Rochester

17033

Pennsylvania State University, Hershey

19104

University of Pennsylvania, Philadelphia

27599

University of North Carolina, Chapel Hill

28204

Atrium Health Carolinas Healthcare System, Charlotte

30912

Augusta University, Augusta

48034

Wayne State University, Southfield

73104

University of Oklahoma, Oklahoma City

84132

University of Utah, Salt Lake City

94115

University of California San Francisco, San Francisco

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Penn State University

OTHER

collaborator

Augusta University

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of North Carolina

OTHER

collaborator

University of Oklahoma

OTHER

collaborator

University of Pennsylvania

OTHER

lead

Yale University

OTHER

NCT02432209 - Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility | Biotech Hunter | Biotech Hunter