InfertilityNCT01668212
Perifollicular Doppler in Natural Cycle In Vitro Fertilization
An observational study of Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to May 2013
- Phase
- Observational
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Women following In Vitro Fertilization cycle
Who may be able to join
- Patient with a natural In Vitro Fertilization cycle.
- Patient under 38 years old
- Body mass indice under 35
- Ovulatory cycles between 20-35 days
Who cannot join
- Patient with a stimulation In Vitro Fertilization cycle
- Patient with a naturalIn Vitro Fertilization cycle with egg donor
- Patient with a natural In Vitro Fertilization cycle with freezing embryo
- Smoking patient
- Diabetic patient
- Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator
Show all 10Show fewer
- Body mass indice over 35
- Patient over 38 years old
- Patient without ovulation or cycle over 35 days
- Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or micro TESE
Trial locations and contacts
1 site in 1 country.
About this study
Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.
The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.
- Conditions
- Infertility
- Being tested
- Doppler ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundProcedure or surgery
Doppler Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| natural In Vitro Fertilization cycle | Patient doing following natural In Vitro fertilization cycle Receives: Procedure: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality perifollicular doppler and quality of the oocyte
The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine Delrieu, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668212
- Sponsor's protocol ID
- OVO-11-01
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2012
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perifollicular Doppler in Natural Cycle In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01668212
- Acronym / sponsor ID
- OVO-11-01
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- First posted
- 20 Aug 2012 (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.
Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.
The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| natural In Vitro Fertilization cycle | – | Procedure: Doppler ultrasoundPatient doing following natural In Vitro fertilization cycle |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women following In Vitro Fertilization cycle
Key inclusion criteria (4 listed)
- Patient with a natural In Vitro Fertilization cycle.
- Patient under 38 years old
- Body mass indice under 35
- Ovulatory cycles between 20-35 days
Key exclusion criteria (10 listed)
- Patient with a stimulation In Vitro Fertilization cycle
- Patient with a naturalIn Vitro Fertilization cycle with egg donor
- Patient with a natural In Vitro Fertilization cycle with freezing embryo
- Smoking patient
- Diabetic patient
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 |
|---|---|---|
| Doppler ultrasoundDoppler Ultrasound | Procedure or surgery | natural In Vitro Fertilization cycle |
Primary outcome
Quality perifollicular doppler and quality of the oocyte
Time frame: 2 weeks
The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH).
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 24 Jun 2013.
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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.
Delphine Delrieu, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Clinique Ovo at 1 site in Canada.
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 4 inclusion and 10 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 24 Jun 2013. 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 Canada. 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?
Quality perifollicular doppler and quality of the oocyte (time frame: 2 weeks). 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 24 Jun 2013.