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

Summary

A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification program with tracked increased physical activity and weight loss (intensive) compared to recommendations to tracking of increased physical activity alone with weight maintenance (standard) in women with obesity and unexplained infertility. This 16 week period of lifestyle modification will be followed by an open label empiric infertility treatment regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and intrauterine insemination (IUI).

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.

Sponsors & Collaborators

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

  collaborator NIH

• Penn State University

  collaborator OTHER

• Augusta University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Nanette Santoro, MD · University of Colorado, Denver

• Heping Zhang, PhD · Yale University

• Richard Legro, MD · Penn State University

• Michael Diamond, MD · Augusta University

• Marcelle Cedars, MD · University of California, San Francisco

• Anne Steiner, MD MPH · Univeristy of North Carolina

• Karl Hansen, MD PhD · University of Oklahoma

• Christos Coutifaris, MD PhD · University of Pennsylvania

• Esther Eisenberg, MD MPH · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2019-11-30

Completion

2020-05-31

Countries

• United States

Study Locations