FertilityPhase 2NCT00161395
Study of Time to Pregnancy in Normal Fertility
A Phase 2 study testing Instruction in the Creighton Model Fertility Care System and Preconception advice in people with Fertility and Pregnancy, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Instruction in the Creighton Model Fertility Care System and Preconception advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Mar 2007
- Phase
- Phase 2
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- couple with prior pregnancy within the past 8 years
Who cannot join
- any history that suggests subfertility
- any history that suggests a medical contraindication for pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Dept. Family and Preventive Medicine
Salt Lake City, Utah, 84108
About this study
Official title: Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.
Read the detailed description
Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.
All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.
All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.
The primary outcome is time to pregnancy.
- Being tested
- Instruction in the Creighton Model Fertility Care System, Preconception advice
- Keywords
- fertility, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction in the Creighton Model Fertility Care SystemBehavioural
Also called Fertility awareness instruction.
Instruction in the Creighton Model Fertility Care System.
Preconception adviceBehavioural
Preconception advice for diet and frequency of intercourse.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Preconception advice. Receives: Behavioral: Preconception advice |
| 2 | Experimental | Instruction in the Creighton Model Fertility Care System. Receives: Behavioral: Instruction in the Creighton Model Fertility Care System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Pregnancy
Measured: Up to one year.
Secondary outcomes (1)
Distribution of coitus within "fertile" days of menstrual cycle
Measured: Seven menstrual cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionAug 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Joseph B Stanford, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161395
- Sponsor's protocol ID
- K23HD001479
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.
PubMed 25225008
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
- ClinicalTrials.gov ID
- NCT00161395
- Acronym / sponsor ID
- K23HD001479
- Keywords
- fertility, pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Sep 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 study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.
Detailed description
Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.
All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.
All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.
The primary outcome is time to pregnancy.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Preconception advicePreconception advice. |
| 2 | Experimental | Behavioral: Instruction in the Creighton Model Fertility Care SystemInstruction in the Creighton Model Fertility Care System. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- couple with prior pregnancy within the past 8 years
Key exclusion criteria (2 listed)
- any history that suggests subfertility
- any history that suggests a medical contraindication for pregnancy
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 |
|---|---|---|
| Instruction in the Creighton Model Fertility Care SystemAlso: Fertility awareness instruction.Instruction in the Creighton Model Fertility Care System. | Behavioural | 2 |
| Preconception advicePreconception advice for diet and frequency of intercourse. | Behavioural | 1 |
Primary outcome
Time to Pregnancy
Time frame: Up to one year.
1 secondary outcome
Distribution of coitus within "fertile" days of menstrual cycle
Time frame: Seven menstrual cycles.
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 16 May 2008.
- Derived from this study: PubMed 25225008Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.
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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.
Joseph B Stanford, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instruction in the Creighton Model Fertility Care System and Preconception advice in people with Fertility and Pregnancy, run by University of Utah at 1 site 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 1 inclusion and 2 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 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to Pregnancy (time frame: Up to one year.). 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 NCT00161395, which also lists 1 linked publication.
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 16 May 2008.