A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial.
OBJECTIVE
To determine the value of gonadotropin/intrauterine insemination (FSH/IUI) therapy for infertile women aged 21-39 years.


METHODS
Randomized controlled trial.


METHODS
Academic medical center associated with a private infertility center.


METHODS
Couples with unexplained infertility.


METHODS
Couples were randomized to receive either conventional treatment (n=247) with three cycles of clomiphene citrate (CC)/IUI, three cycles of FSH/IUI, and up to six cycles of IVF or an accelerated treatment (n=256) that omitted the three cycles of FSH/IUI.


METHODS
The time it took to establish a pregnancy that led to a live birth and cost-effectiveness, defined as the ratio of the sum of all health insurance charges between randomization and delivery divided by the number of couples delivering at least one live-born baby.


RESULTS
An increased rate of pregnancy was observed in the accelerated arm (hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.00-1.56) compared with the conventional arm. Median time to pregnancy was 8 and 11 months in the accelerated and conventional arms, respectively. Per cycle pregnancy rates for CC/IUI, FSH/IUI, and IVF were 7.6%, 9.8%, and 30.7%, respectively. Average charges per delivery were $9,800 lower (95% CI, $25,100 lower to $3,900 higher) in the accelerated arm compared to conventional treatment. The observed incremental difference was a savings of $2,624 per couple for accelerated treatment and 0.06 more deliveries.


CONCLUSIONS
A randomized clinical trial demonstrated that FSH/IUI treatment was of no added value.
Reindollar
Richard H
RH
Department of Obstetrics and Gynecology, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA. Richard.H.Reidollar@Hitchcock.org
Regan
Meredith M
MM
Neumann
Peter J
PJ
Levine
Bat-Sheva
BS
Thornton
Kim L
KL
Alper
Michael M
MM
Goldman
Marlene B
MB
D000328:Adult; D002138:Calibration; D002985:Clinical Protocols / Q000592:standards; D002996:Clomiphene / Q000627:therapeutic use; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use; D006062:Gonadotropins / Q000627:therapeutic use; D017048:Health Care Costs; D006801:Humans; D007246:Infertility / Q000191:economics / Q000628:therapy*; D008297:Male; D010062:Ovulation Induction; D011247:Pregnancy; D018873:Pregnancy Rate; D027724:Reproductive Techniques, Assisted / Q000191:economics / Q000592:standards; D013997:Time Factors; D055815:Young Adult
D005300:Fertility Agents, Female; D006062:Gonadotropins; D002996:Clomiphene