Pregnancy Clinical Trial
Official title:
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
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.
Patient Population
The population will consist of 900 women up to and including women ≥18 to ≤40 years years of
age (at time of randomization) desirous of conceiving who will be recruited over
approximately a two year period from the Reproductive Medicine Network (RMN) clinical sites
and possibly from the Specialized Cooperative Center Programs in Reproductive Research
(SCCPIR) sites, through public notification programs.
Study Design
This will be a multi-center, prospective, partially blinded clinical trial of gonadotropins
vs. clomiphene citrate vs. aromatase inhibitors. The randomization scheme will be
coordinated through the data coordination center (DCC) and the randomization will be
stratified by each participating site and within each site for ages 18-34 and 35-40.
Treatment
Patients will be randomized to receive either FSH, CC, or an AI according to randomization
tables generated by a computer randomization program. Treatment assignments will be blocked
by site and age group. Subjects randomized to pill treatment will receive medication in
double blinded fashion, receiving one type of pill (overcoated CC or AI). Subjects
randomized to injectable medication(FSH) will receive vials of medication.
Primary efficacy parameter
Multiple gestation rate following recruitment of multiple follicular development with an AI,
as compared to CC and FSH.
Secondary efficacy parameters
Rate of pregnancy obtained, live birth rate, and time to pregnancy following administration
of an aromatase inhibitor, as compared to CC and FSH as well as the live birth rate of
multiple gestation pregnancies.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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