Conventional Infertility Treatment vs. Fast Track to IVF

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT00260091

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

503

Starts

1999-08-01

Expected to finish

2006-04-01

Last updated by the study team

2013-11-18

Who can join

Age: 21 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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