Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260091
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2005-11-29
Brief Title:
Conventional Infertility Treatment vs Fast Track to IVF
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Conventional Infertility Therapy vs Fast Track to IVF
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASTT
Brief 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 clomipheneIUI It then progresses to FSHIUI and if pregnancy is not achieved to IVF The fast track to IVF strategy begins with clomipheneIUI if pregnancy does not result these patients bypass FSHIUI 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None