NCT00260091

Conventional Infertility Treatment vs. Fast Track to IVF

Conventional Infertility Therapy vs. Fast Track to IVF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Infertility

Interventions

Type	Name	Description
PROCEDURE	intrauterine insemination	An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.
PROCEDURE	infertility	This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.

Timeline

• Start date: 1999-08-01
• Primary completion: 2005-08-01
• Completion: 2006-04-01
• First posted: 2005-12-01
• Last updated: 2013-11-18

Locations

7 sites across 1 country: United States