Conventional Infertility Treatment vs. Fast Track to IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

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
    

Intervention name(s): intrauterine insemination; infertility
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): assisted reproductive technologies; IUI; assisted reproductive technologies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Advanced maternal age; Pregnancy; Reproductive health; Fertility treatment; Reproduction