Repeated IVF FailurePhase 2Thrive-IVF F/UNCT01978561
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
A Phase 2 study testing Post dosing with NT100 in people with Repeated IVF Failure, run by Nora Therapeutics, Inc..
Trial summary
The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Repeated IVF Failure
- What is being tested?
- Post dosing with NT100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Sep 2015
- 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 21 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least one dose of study drug administered in NT-03
- Ongoing clinical pregnancy at Week 10 of gestation
- Able and willing to enroll in NT-04
Who cannot join
- None
About this study
Official title: Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.
Read the detailed description
NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.
In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.
Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.
Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.
Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.
- Conditions
- Repeated IVF Failure
- Being tested
- Post dosing with NT100, Post dosing with Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post dosing with NT100Biological
Post dosing with PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Follow-Up after dosing with NT100 Dose 1 | Experimental | Follow-Up after dosing with NT100 Dose 1 Receives: Biological: Post dosing with NT100 |
| Follow-Up after dosing with NT100 Dose 2 | Experimental | Follow-Up after dosing with NT100 Dose 2 Receives: Biological: Post dosing with NT100 |
| Follow-Up after dosing with Placebo | Placebo comparator | Follow-Up after dosing with Placebo Receives: Other: Post dosing with Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of live births
Measured: Within approximately 7 months after NT-03
Secondary outcomes (4)
Number of stillbirths
Measured: Within approximately 7 months after study NT-03
Number of spontaneous abortions (miscarriages)
Measured: Within approximately 7 months after study NT-03
Number of congenital anomalies
Measured: Up to 4 weeks after birth
Number of severe neonatal adverse events
Measured: Up to 4 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated IVF FailureStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nora Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978561
- Sponsor's protocol ID
- NT-04
- Acronym
- Thrive-IVF F/U
- Status last verified
- Sep 2015
- First submitted
- 1 Nov 2013
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
- ClinicalTrials.gov ID
- NCT01978561
- Acronym / sponsor ID
- Thrive-IVF F/U / NT-04
- Conditions
- Repeated IVF Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nora Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Nov 2013 (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 evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.
Detailed description
NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.
In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.
Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.
Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.
Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Follow-Up after dosing with NT100 Dose 1 | Experimental | Biological: Post dosing with NT100Follow-Up after dosing with NT100 Dose 1 |
| Follow-Up after dosing with NT100 Dose 2 | Experimental | Biological: Post dosing with NT100Follow-Up after dosing with NT100 Dose 2 |
| Follow-Up after dosing with Placebo | Placebo comparator | Other: Post dosing with PlaceboFollow-Up after dosing with Placebo |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least one dose of study drug administered in NT-03
- Ongoing clinical pregnancy at Week 10 of gestation
- Able and willing to enroll in NT-04
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Post dosing with NT100 | Biological | Follow-Up after dosing with NT100 Dose 1, Follow-Up after dosing with NT100 Dose 2 |
| Post dosing with Placebo | Other | Follow-Up after dosing with Placebo |
Primary outcome
Number of live births
Time frame: Within approximately 7 months after NT-03
4 secondary outcomes
Number of stillbirths
Time frame: Within approximately 7 months after study NT-03
Number of spontaneous abortions (miscarriages)
Time frame: Within approximately 7 months after study NT-03
Number of congenital anomalies
Time frame: Up to 4 weeks after birth
Number of severe neonatal adverse events
Time frame: Up to 4 weeks after birth
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 14 Sep 2015.
- Study NT-03, Thrive-IVF Research StudyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post dosing with NT100 in people with Repeated IVF Failure, run by Nora Therapeutics, Inc..
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 3 inclusion and 1 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Number of live births (time frame: Within approximately 7 months after NT-03). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2015.