InfertilityNCT01480115
A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve
An observational study of Infertility, run by Meir Medical Center at 1 site in Israel.
Trial summary
The ultrasound unit in Meir Medical Center developed new software to automated ovarian follicle count on the basis of 3D US. The investigators intent to evaluate this software at two steps: To compared the abilities of the software to physician follicle count. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ultrasound examination for AFC evaluation
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Nov 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study group will include women faced the fertility unit in Meir Medical Center. Each woman at her first evaluation will invite to volunteer. Also woman during a natural course treatment will invite to volunteer.
Who may be able to join
- woman under age 40 years all
- woman at evaluation before beginning of fertility treatment
- woman with regular menstrual cycle
Who cannot join
- woman who treat with ovulation induction
Trial locations and contacts
1 site in 1 country.
About this study
The ultrasound unit in Meir Medical Center developed new software to automated ovarian follicle count on the basis of 3D US. The investigators intent to evaluate this software at two steps:
- To compared the abilities of the software to physician follicle count.
- To evaluate with the software the antral follicle count, as expression to ovarian reserve at 3 different time of the month.
The investigators believe that the software measurement of the small follicle can be better than the common antral follicle count that is use today, and by this accurate evaluation of the small follicle the investigators can evaluate the ovarian reserve at any time of the mount, and not only at the early follicular phase that use today.
Read the detailed description
Antral follicle count (AFC) is one of the methods to evaluate ovarian reserve. But this method is not that straightforward with a lot of inter and intra observe variation. In attempt to overcome this problems we going the verified a new software for automated AFC.
At the first step we will compare the human count and the software count of the AFC in 150 exams of ovaries at 3D US.
At the second step we will use the software to evaluate ovarian reserve at 50 women before fertility treatment. This woman will be questioned about epidemiologic data (age, ethnicity, medical history) and evaluate at the early follicular phase with blood test for follicle stimulating hormone, luteinizing hormone , E2, anti-mullerian hormone , Prolactin, thyroid-stimulating hormone, Testosterone, Progesterone, 17-hydroxyprogesterone, dehydroepiandrosterone-Sulphate. The evaluation of the AFC by US will be at early follicular phase, late follicular phase and mid luteal phase
- Conditions
- Infertility
- Being tested
- ultrasound examination for AFC evaluation
- Keywords
- antral follicle count, automated antral follicle count, ovarian reserve
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examination for AFC evaluationOther
Ultrasound examination three times during the menstrual cycle to measure the AFC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.
Measured: Within the 28-35 days of the menstrual cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startApr 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roni Tepper, professor, Study director, Meir Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480115
- Sponsor's protocol ID
- MMC11102-11CTLI
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hendriks DJ, Mol BW, Bancsi LF, Te Velde ER, Broekmans FJ. Antral follicle count in the prediction of poor ovarian response and pregnancy after in vitro fertilization: a meta-analysis and comparison with basal follicle-stimulating hormone level. Fertil Steril. 2005 Feb;83(2):291-301. doi: 10.1016/j.fertnstert.2004.10.011.
PubMed 15705365Hendriks DJ, Kwee J, Mol BW, te Velde ER, Broekmans FJ. Ultrasonography as a tool for the prediction of outcome in IVF patients: a comparative meta-analysis of ovarian volume and antral follicle count. Fertil Steril. 2007 Apr;87(4):764-75. doi: 10.1016/j.fertnstert.2006.11.006. Epub 2007 Jan 18.
PubMed 17239869Raine-Fenning N, Jayaprakasan K, Clewes J. Automated follicle tracking facilitates standardization and may improve work flow. Ultrasound Obstet Gynecol. 2007 Dec;30(7):1015-8. doi: 10.1002/uog.5222. No abstract available.
PubMed 18044823Styer AK, Toth TL. Antral follicle count in clinical practice: building the bridge from ovarian reserve to in vitro fertilization outcome. Fertil Steril. 2011 Feb;95(2):480-1; discussion 484-5. doi: 10.1016/j.fertnstert.2010.11.054. Epub 2010 Dec 23.
PubMed 21183169Hsu A, Arny M, Knee AB, Bell C, Cook E, Novak AL, Grow DR. Antral follicle count in clinical practice: analyzing clinical relevance. Fertil Steril. 2011 Feb;95(2):474-9. doi: 10.1016/j.fertnstert.2010.03.023.
PubMed 20434151Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
PubMed 21575853Al-Azemi M, Killick SR, Duffy S, Pye C, Refaat B, Hill N, Ledger W. Multi-marker assessment of ovarian reserve predicts oocyte yield after ovulation induction. Hum Reprod. 2011 Feb;26(2):414-22. doi: 10.1093/humrep/deq339. Epub 2010 Dec 8.
PubMed 21147822Deb S, Jayaprakasan K, Campbell BK, Clewes JS, Johnson IR, Raine-Fenning NJ. Intraobserver and interobserver reliability of automated antral follicle counts made using three-dimensional ultrasound and SonoAVC. Ultrasound Obstet Gynecol. 2009 Apr;33(4):477-83. doi: 10.1002/uog.6310.
PubMed 19212944Murtinger M, Aburumieh A, Rubner P, Eichel V, Zech MH, Zech NH. Improved monitoring of ovarian stimulation using 3D transvaginal ultrasound plus automated volume count. Reprod Biomed Online. 2009 Nov;19(5):695-9. doi: 10.1016/j.rbmo.2009.09.008.
PubMed 20021717Raine-Fenning N, Jayaprakasan K, Deb S, Clewes J, Joergner I, Dehghani Bonaki S, Johnson I. Automated follicle tracking improves measurement reliability in patients undergoing ovarian stimulation. Reprod Biomed Online. 2009 May;18(5):658-63. doi: 10.1016/s1472-6483(10)60010-7.
PubMed 19549444
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01480115
- Acronym / sponsor ID
- MMC11102-11CTLI
- Conditions
- Infertility
- Keywords
- antral follicle count, automated antral follicle count, ovarian reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 28 Nov 2011 (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 ultrasound unit in Meir Medical Center developed new software to automated ovarian follicle count on the basis of 3D US. The investigators intent to evaluate this software at two steps:
- To compared the abilities of the software to physician follicle count.
- To evaluate with the software the antral follicle count, as expression to ovarian reserve at 3 different time of the month.
The investigators believe that the software measurement of the small follicle can be better than the common antral follicle count that is use today, and by this accurate evaluation of the small follicle the investigators can evaluate the ovarian reserve at any time of the mount, and not only at the early follicular phase that use today.
Detailed description
Antral follicle count (AFC) is one of the methods to evaluate ovarian reserve. But this method is not that straightforward with a lot of inter and intra observe variation. In attempt to overcome this problems we going the verified a new software for automated AFC.
At the first step we will compare the human count and the software count of the AFC in 150 exams of ovaries at 3D US.
At the second step we will use the software to evaluate ovarian reserve at 50 women before fertility treatment. This woman will be questioned about epidemiologic data (age, ethnicity, medical history) and evaluate at the early follicular phase with blood test for follicle stimulating hormone, luteinizing hormone , E2, anti-mullerian hormone , Prolactin, thyroid-stimulating hormone, Testosterone, Progesterone, 17-hydroxyprogesterone, dehydroepiandrosterone-Sulphate. The evaluation of the AFC by US will be at early follicular phase, late follicular phase and mid luteal phase
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group will include women faced the fertility unit in Meir Medical Center. Each woman at her first evaluation will invite to volunteer. Also woman during a natural course treatment will invite to volunteer.
Key inclusion criteria (3 listed)
- woman under age 40 years all
- woman at evaluation before beginning of fertility treatment
- woman with regular menstrual cycle
Key exclusion criteria (1 listed)
- woman who treat with ovulation induction
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 |
|---|---|---|
| ultrasound examination for AFC evaluationUltrasound examination three times during the menstrual cycle to measure the AFC. | Other | – |
Primary outcome
Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.
Time frame: Within the 28-35 days of the menstrual cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Background: PubMed 15705365Hendriks DJ, Mol BW, Bancsi LF, Te Velde ER, Broekmans FJ. Antral follicle count in the prediction of poor ovarian response and pregnancy after in vitro fertilization: a meta-analysis and comparison with basal follicle-stimulating hormone level. Fertil Steril. 2005 Feb;83(2):291-301. doi: 10.1016/j.fertnstert.2004.10.011.
- Background: PubMed 17239869Hendriks DJ, Kwee J, Mol BW, te Velde ER, Broekmans FJ. Ultrasonography as a tool for the prediction of outcome in IVF patients: a comparative meta-analysis of ovarian volume and antral follicle count. Fertil Steril. 2007 Apr;87(4):764-75. doi: 10.1016/j.fertnstert.2006.11.006. Epub 2007 Jan 18.
- Background: PubMed 18044823Raine-Fenning N, Jayaprakasan K, Clewes J. Automated follicle tracking facilitates standardization and may improve work flow. Ultrasound Obstet Gynecol. 2007 Dec;30(7):1015-8. doi: 10.1002/uog.5222. No abstract available.
- Background: PubMed 21183169Styer AK, Toth TL. Antral follicle count in clinical practice: building the bridge from ovarian reserve to in vitro fertilization outcome. Fertil Steril. 2011 Feb;95(2):480-1; discussion 484-5. doi: 10.1016/j.fertnstert.2010.11.054. Epub 2010 Dec 23.
- Background: PubMed 20434151Hsu A, Arny M, Knee AB, Bell C, Cook E, Novak AL, Grow DR. Antral follicle count in clinical practice: analyzing clinical relevance. Fertil Steril. 2011 Feb;95(2):474-9. doi: 10.1016/j.fertnstert.2010.03.023.
- Background: PubMed 21575853Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
- Background: PubMed 21147822Al-Azemi M, Killick SR, Duffy S, Pye C, Refaat B, Hill N, Ledger W. Multi-marker assessment of ovarian reserve predicts oocyte yield after ovulation induction. Hum Reprod. 2011 Feb;26(2):414-22. doi: 10.1093/humrep/deq339. Epub 2010 Dec 8.
- Background: PubMed 19212944Deb S, Jayaprakasan K, Campbell BK, Clewes JS, Johnson IR, Raine-Fenning NJ. Intraobserver and interobserver reliability of automated antral follicle counts made using three-dimensional ultrasound and SonoAVC. Ultrasound Obstet Gynecol. 2009 Apr;33(4):477-83. doi: 10.1002/uog.6310.
- Background: PubMed 20021717Murtinger M, Aburumieh A, Rubner P, Eichel V, Zech MH, Zech NH. Improved monitoring of ovarian stimulation using 3D transvaginal ultrasound plus automated volume count. Reprod Biomed Online. 2009 Nov;19(5):695-9. doi: 10.1016/j.rbmo.2009.09.008.
- Background: PubMed 19549444Raine-Fenning N, Jayaprakasan K, Deb S, Clewes J, Joergner I, Dehghani Bonaki S, Johnson I. Automated follicle tracking improves measurement reliability in patients undergoing ovarian stimulation. Reprod Biomed Online. 2009 May;18(5):658-63. doi: 10.1016/s1472-6483(10)60010-7.
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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.
Roni Tepper, professor study director
Meir Medical Center Israel
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 Meir Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roni Tepper, professor (972-9-7472871, tepper@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation. (time frame: Within the 28-35 days of the menstrual cycle.). 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 NCT01480115, which also lists 10 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 12 Mar 2013.