InfertilityFASTTNCT00260091
Conventional Infertility Treatment vs. Fast Track to IVF
A study testing intrauterine insemination and infertility in people with Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- intrauterine insemination and infertility
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 1999to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
Boston IVf
Brookline, Massachusetts, 02446
Harvard Vanguard Medical Associates
Burlington, Massachusetts, 01803
Boston IVF
Quincy, Massachusetts, 02169
Harvard Vanguard Medical Associates
Quincy, Massachusetts, 02169
Boston IVF
Waltham, Massachusetts, 02451
Harvard Vanguard Medical Associates
Wellesley, Massachusetts, 02481
About this study
Official 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.
Read the 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 otherwise be candidates for ovulation induction and IUI as their initial treatment. The two therapies compared are conventional treatment and fast track to IVF. Conventional therapy is a cost-conscious progressive treatment strategy that begins with the least invasive form of ovulation induction, clomiphene/IUI. It then progresses to FSH/IUI and, if pregnancy is not achieved, to IVF. The fast track to IVF strategy begins with clomiphene/IUI; if pregnancy does not result, these patients bypass FSH/IUI and move directly to IVF. We hypothesize that the fast track to IVF therapy results in a higher pregnancy rate, lower rates of medical complications during treatment, lower rates of pregnancy complications, and costs no more than conventional infertility treatment.
The trial has the following specific aims:
Aim 1: To compare the number of deliveries per initiated cycle, the proportion of women with a clinically recognized intrauterine pregnancy, and the time to clinical pregnancy between fast track to IVF and the conventional treatment arms of the clinical trial.
Aim 2: To compare the frequency of infertility treatment complications between the fast track to IVF arm and the conventional treatment arm.
Aim 3: To compare the occurrence of pregnancy complications between the fast track to IVF arm and the conventional treatment arm.
Aim 4: To evaluate the costs and cost effectiveness of the two alternative treatment strategies by comparing the direct and indirect medical costs between the fast track to IVF and conventional treatment arms of the clinical trial.
This is a collaborative study between Boston IVF, Harvard Vanguard Medical Associates, Harvard School of Public Health, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan.
Total Enrollment: 503 Couples
- Conditions
- Infertility
- Being tested
- intrauterine insemination, infertility
- Keywords
- Infertility, Advanced maternal age, Pregnancy, Reproductive health, Fertility treatment, Reproduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrauterine inseminationProcedure or surgery
Also called assisted reproductive technologies, IUI
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.
infertilityProcedure or surgery
Also called assisted reproductive technologies
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.
| Study group | Role | What they receive |
|---|---|---|
| I. | Active comparator | Conventional infertility therapy Receives: Procedure: intrauterine insemination; Procedure: infertility |
| II. | Active comparator | Fast track to in vitro fertilization therapy Receives: Procedure: intrauterine insemination; Procedure: infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startAug 1999
- Primary completionAug 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard H. Reindollar, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New HampshireMarlene B. Goldman, Sc.D., Study director, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260091
- Sponsor's protocol ID
- 1R01HD038561
- Acronym
- FASTT
- Status last verified
- Jan 2009
- First submitted
- 29 Nov 2005
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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)
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.
PubMed 24355050
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Infertility Therapy vs. Fast Track to IVF
- ClinicalTrials.gov ID
- NCT00260091
- Acronym / sponsor ID
- FASTT / 1R01HD038561
- Conditions
- Infertility
- Keywords
- Infertility, Advanced maternal age, Pregnancy, Reproductive health, Fertility treatment, Reproduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 1999
- Primary completion
- Aug 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 otherwise be candidates for ovulation induction and IUI as their initial treatment. The two therapies compared are conventional treatment and fast track to IVF. Conventional therapy is a cost-conscious progressive treatment strategy that begins with the least invasive form of ovulation induction, clomiphene/IUI. It then progresses to FSH/IUI and, if pregnancy is not achieved, to IVF. The fast track to IVF strategy begins with clomiphene/IUI; if pregnancy does not result, these patients bypass FSH/IUI and move directly to IVF. We hypothesize that the fast track to IVF therapy results in a higher pregnancy rate, lower rates of medical complications during treatment, lower rates of pregnancy complications, and costs no more than conventional infertility treatment.
The trial has the following specific aims:
Aim 1: To compare the number of deliveries per initiated cycle, the proportion of women with a clinically recognized intrauterine pregnancy, and the time to clinical pregnancy between fast track to IVF and the conventional treatment arms of the clinical trial.
Aim 2: To compare the frequency of infertility treatment complications between the fast track to IVF arm and the conventional treatment arm.
Aim 3: To compare the occurrence of pregnancy complications between the fast track to IVF arm and the conventional treatment arm.
Aim 4: To evaluate the costs and cost effectiveness of the two alternative treatment strategies by comparing the direct and indirect medical costs between the fast track to IVF and conventional treatment arms of the clinical trial.
This is a collaborative study between Boston IVF, Harvard Vanguard Medical Associates, Harvard School of Public Health, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan.
Total Enrollment: 503 Couples
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I. | Active comparator | Procedure: intrauterine insemination, Procedure: infertilityConventional infertility therapy |
| II. | Active comparator | Procedure: intrauterine insemination, Procedure: infertilityFast track to in vitro fertilization therapy |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrauterine inseminationAlso: assisted reproductive technologies, IUIAn 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. | Procedure or surgery | I., II. |
| infertilityAlso: assisted reproductive technologiesThis 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. | Procedure or surgery | I., II. |
Primary outcome
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.
Time frame: at end of study
1 secondary outcome
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.
Time frame: at end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Results publicationGoldman 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.
- Results publicationReindollar 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)
- Derived from this study: PubMed 24355050Ruder 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.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard H. Reindollar, M.D. principal investigator
Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire
Marlene B. Goldman, Sc.D. study director
Dartmouth-Hitchcock Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrauterine insemination and infertility in people with Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260091, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.