Status:
COMPLETED
Conventional Infertility Treatment vs. Fast Track to IVF
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infertility
Eligibility:
All Genders
21-40 years
Phase:
NA
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 trea...
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 ot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT00260091
Start Date
August 1 1999
End Date
April 1 2006
Last Update
November 18 2013
Active Locations (7)
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1
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
2
Boston IVf
Brookline, Massachusetts, United States, 02446
3
Harvard Vanguard Medical Associates
Burlington, Massachusetts, United States, 01803
4
Boston IVF
Quincy, Massachusetts, United States, 02169