NCT00260091

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 treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 18, 2013

Status Verified

January 1, 2009

Enrollment Period

6 years

First QC Date

November 29, 2005

Last Update Submit

November 15, 2013

Conditions

Infertility

Keywords

InfertilityAdvanced maternal agePregnancyReproductive healthFertility treatmentReproduction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

I.

ACTIVE COMPARATOR

Conventional infertility therapy

Procedure: intrauterine inseminationProcedure: infertility

II.

ACTIVE COMPARATOR

Fast track to in vitro fertilization therapy

Procedure: intrauterine inseminationProcedure: infertility

Interventions

intrauterine inseminationPROCEDURE

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.

Also known as: assisted reproductive technologies, IUI
I.II.
infertilityPROCEDURE

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.

Also known as: assisted reproductive technologies
I.II.

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Location

Boston IVf

Brookline, Massachusetts, 02446, United States

Location

Harvard Vanguard Medical Associates

Burlington, Massachusetts, 01803, United States

Location

Boston IVF

Quincy, Massachusetts, 02169, United States

Location

Harvard Vanguard Medical Associates

Quincy, Massachusetts, 02169, United States

Location

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Harvard Vanguard Medical Associates

Wellesley, Massachusetts, 02481, United States

Location

Related Publications (3)

  • 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 Soc Gynecol Inves 2005;12(2) Suppl:201A.

    RESULT

  • 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 Treatment (FASTT) Trial [abstract O-108]. ASRM, Washington D.C. Fertil Steril 2007;88(1) Suppl:S41. (General Program Prize Paper Award)

    RESULT

  • Ruder EH, Hartman TJ, Reindollar RH, Goldman MB. Female dietary antioxidant intake and time to pregnancy among couples treated for unexplained infertility. Fertil Steril. 2014 Mar;101(3):759-66. doi: 10.1016/j.fertnstert.2013.11.008. Epub 2013 Dec 17.

    PMID: 24355050DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Richard H. Reindollar, M.D.

    Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire

    PRINCIPAL INVESTIGATOR

  • Marlene B. Goldman, Sc.D.

    Dartmouth-Hitchcock Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

August 1, 1999

Primary Completion

August 1, 2005

Study Completion

April 1, 2006

Last Updated

November 18, 2013

Record last verified: 2009-01

Locations

US(7)