Infertility Clinical Trial
— FASTTOfficial title:
Conventional Infertility Therapy vs. Fast Track to IVF
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.
Status | Completed |
Enrollment | 503 |
Est. completion date | April 2006 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse. - Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict criteria, or >5 million total motile sperm on IUI prep. - Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube. - Patients with surgically corrected stages I and II endometriosis will be included. - Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study). - Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for inclusion, prior to any gonadotropin therapy. - Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin. - Female body mass index = 38. Exclusion Criteria: - Previous tubal reconstructive surgery in which the pelvis was not restored to functional. - Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes. - A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis. - One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent. - Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict criteria, or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded. - Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins. - Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL. - Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET). - Female body mass index > 38. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harvard Vanguard Medical Associates | Boston | Massachusetts |
United States | Boston IVf | Brookline | Massachusetts |
United States | Harvard Vanguard Medical Associates | Burlington | Massachusetts |
United States | Boston IVF | Quincy | Massachusetts |
United States | Harvard Vanguard Medical Associates | Quincy | Massachusetts |
United States | Boston IVF | Waltham | Massachusetts |
United States | Harvard Vanguard Medical Associates | Wellesley | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Goldman MB, Hartman TJ, Regan MM, Thornton KL, Neumann PJ, Alper MM, Reindollar RH. Dietary antioxidant status in couples with unexplained infertility: the fast track and standard treatment trial (FASTT). [abstract 361]. SGI, Los Angeles, California. J So
Reindollar RH, Regan MM, Neumann PJ, Thornton KL, Alper MM, Goldman MB. A randomized controlled trial of 503 couples assigned to conventional infertility treatment or an accelerated track to IVF: Preliminary results of the Fast Track and Standard Treatmen
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. | at end of study | No | |
Secondary | Demographics and baseline variables will be collected, including: medical and reproductive history, age, education, income, race, nutritional history, smoking history, and clinical variables related to infertility diagnosis and treatment. | at end of study | No |
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