Conventional Infertility Treatment vs. Fast Track to IVF — FASTT  

Infertility Clinical Trial

Official title: Conventional Infertility Therapy vs. Fast Track to IVF

Status Completed

Clinical Trial Summary

The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.

Clinical Trial Description

This is a randomized clinical trial to evaluate the efficacy, adverse events, and particularly cost and cost-effectiveness of two alternative infertility treatment strategies for patients who would otherwise be candidates for ovulation induction and IUI as their initial treatment. The two therapies compared are conventional treatment and fast track to IVF. Conventional therapy is a cost-conscious progressive treatment strategy that begins with the least invasive form of ovulation induction, clomiphene/IUI. It then progresses to FSH/IUI and, if pregnancy is not achieved, to IVF. The fast track to IVF strategy begins with clomiphene/IUI; if pregnancy does not result, these patients bypass FSH/IUI and move directly to IVF. We hypothesize that the fast track to IVF therapy results in a higher pregnancy rate, lower rates of medical complications during treatment, lower rates of pregnancy complications, and costs no more than conventional infertility treatment.

The trial has the following specific aims:

Aim 1: To compare the number of deliveries per initiated cycle, the proportion of women with a clinically recognized intrauterine pregnancy, and the time to clinical pregnancy between fast track to IVF and the conventional treatment arms of the clinical trial.

Aim 2: To compare the frequency of infertility treatment complications between the fast track to IVF arm and the conventional treatment arm.

Aim 3: To compare the occurrence of pregnancy complications between the fast track to IVF arm and the conventional treatment arm.

Aim 4: To evaluate the costs and cost effectiveness of the two alternative treatment strategies by comparing the direct and indirect medical costs between the fast track to IVF and conventional treatment arms of the clinical trial.

This is a collaborative study between Boston IVF, Harvard Vanguard Medical Associates, Harvard School of Public Health, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan.

Total Enrollment: 503 Couples ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT00260091
• Study type: Interventional
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Status: Completed
• Phase: N/A
• Start date: August 1999
• Completion date: April 2006