Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation

Summary

The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.

Conditions

• Pregnancy
• Unexplained Infertility

Interventions

DRUG

Letrozole (aromatase inhibitor)

A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.

DRUG

Clomiphene Citrate

CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.

DRUG

Follicle Stimulating Hormone (gonadotropin)

A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.

Sponsors & Collaborators

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

  collaborator NIH

• Penn State University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Texas

  collaborator OTHER

• University of Vermont

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

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

• Nanette Santoro, MD · Albert Einstein College of Medicine

• Michael Diamond, MD · Wayne State University

• Richard Legro, MD · Pennsylvania State University College of Medicine

• William Schlaff, MD · University of Colorado Denver Health Science Center

• Gregory Christman, MD · University of Michigan

• Christos Coutifaris, MD · University of Pennsylvania

• Robert Brzyski, MD, PhD · The University of Texas Health Science Center at San Antonio

• Peter Casson, MD · University of Vermont

• Heping Zhang, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2013-10-31

Completion

2014-03-31

Countries

• United States

Study Locations