Return to Results

Conventional Infertility Therapy vs. Fast Track to IVF

new search

Trial Conditions
  • Infertility
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
21  - 40 

Gender:
Both

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.

Gender: Both
Steward Physician(s)
  • Richard H. Reindollar, M.D.
  • Marlene B. Goldman, Sc.D.
Trial Interventions
Procedure
  • intrauterine insemination
  • infertility
Physician Researcher

Investigator Name:

  • Richard H. Reindollar, M.D.
  • Marlene B. Goldman, Sc.D.

Other Information

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase: N/A
Trial ID: NCT00260091
Volunteers:  Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions