InfertilityOvAgeNCT02086318
A New Algorithm to Predict Ovarian Age
An observational study of Infertility and Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial summary
To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Polycystic Ovary Syndrome, Premature Ovarian Failure (POF)
- What is being tested?
- OvAge assessment
- How many people
- 720 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jun 2018
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women
Who may be able to join
- Age between 18 and 55 years
- Consent to participate to the prospective study
- Regular menses at 22 to 35 day interval
Who cannot join
- Estrogen or progestin-containing medications in the month before enrollment
- Gynecological malignancy
- Hypogonadotropic hypogonadism
- Assumption of drugs that can cause menstrual irregularity
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Chair of Obstetrics and Gynecology - University division - UMG
Catanzaro, CZ, 88100
Fulvio Zullo, 39337947003, zullo@unicz.it
Roberta Venturella, MD
About this study
Official title: A New Algorithm to Predict Ovarian Age Combining Clinical, Biochemical and 3D-ultrasonographic Parameters: OvAge
To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance to menopause following the guidelines of the Standards for Reporting of Diagnostic Accuracy initiative (STARD)
Read the detailed description
The normal process of reproductive aging varies considerably among women. This implies that some women remain highly fertile until the fifth decade of their life, whereas others face the loss of natural fertility already in their mid-thirties. Female reproductive aging seems to be largely based on age related changes in ovarian function. Decreasing numbers of follicles, coinciding with diminished oocyte quality, dictate the gradual changes in menstrual cycle regularity and monthly fecundity which inevitable evolution will be menopause. The mechanisms behind the observed gradual decline of the follicle pool and the reduced oocyte quality are far from being fully understood, although recent knowledge regarding the endocrine, paracrine, genetic, and metabolic factors involved has led to a better understanding of this immensely complex puzzle.
Within the context of normal female reproductive aging, as already outlined, large individual variation exists in the age at which the various reproductive events occur. This variation has major implications for the preventive management of age-related decreased fertility and general health risks associated with extremely early menopause in conditions such as POF. Moreover, distance from menopause is an important parameter which can lead clinician's choice in the appropriate timing for surgical treatment of benign gynecological pathologies.
Although chronological age is the most important predictor of physiological ovarian response to endogenous and exogenous Follicle-stimulating Hormone (FSH), both environmental and genetic factors contribute to biological ovarian ageing, so that chronological and biological age are not always equivalent. Among genetic factors able to determine age at which menopause will occur, the most important are the size of the initial oocyte stock, the proportion that undergoes atresia and the rate of initiation of follicles growth. It has been suggested, moreover, that certain single nucleotide polymorphisms (such as regarding FSH receptors genotype) also affect sensitivity to gonadotrophins and ovarian ageing [Alviggi 45]. Environmental factors such as diet, cigarette smoking, regimens of chemotherapy or radiotherapy, endometriosis or ovarian surgery may shorten the functional lifespan of a woman's ovaries too.
Even if the continuous follicles loss will only be recognized in the late stages by cycle irregularity, endocrine and ultrasound markers have emerged over the last decade that may express more accurately the follicle number decline over a long time period. Among endocrine parameters, the most studied and used in clinical practice are FSH, Estradiol (E2) and Anti-Mullerian Hormone (AMH).
Basal FSH, extensively studied over the past few decades, provides the most indirect marker of ovarian reserve. FSH levels increase with advancing age, by reducing the negative feedback on FSH release from the pituitary [broekm vecchio 10]. High FSH levels therefore represent small cohort size. To exclude the possibility that confounding factors, such as E2 levels greater than 50 pg/ml, suppress FSH secretion, this parameters have to be always evaluated together on menstrual cycle days 1-4.
In women with varying degrees of hypergonadotropism (ranging from imminent ovarian failure to full-blown POF), however, the better parameter to assess the extent of ovarian follicle depletion seems to be represented by AMH (Broekm 109). It is a dimeric glycoprotein with autocrine and paracrine actions in follicle development, exclusively produced by granulose cells of preantral (primary and secondary) and small antral follicles (2-7 mm in diameters). The number of small antral follicles is directly related to the total size of the primordial follicle pool (Broekm 68). With the decrease in the number of antral follicles with age, AMH serum levels also become diminished (Br 66, 95, 104) and will invariably become undetectable near menopause (Br 65). Recent studies have indeed suggested that AMH serum levels represent ovarian quantitative reserve (Br 105-107) and may provide an index of age at menopause.
Regarding ultrasound markers, several studies, recently, demonstrated that Antral Follicle Count (AFC), defined as the total number of antral follicles, sized 2-10 mm, present in both ovaries, represents a better marker than either chronological age or basal FSH for assessing the ovarian biological age [alviggi 89] and it has also been correlated with the occurrence of the menopausal transition (broekm 66), indicating that this parameter relates strongly with the quantitative aspects of ovarian reserve.
As for AFC, ovarian volume, measured by vaginal ultrasound, has been associated to the ovarian functional asset and also transvaginal ultrasound with the use of power Doppler is often used to evaluate the blood flow through the ovary in natural cycles. Several studies, moreover, have shown that ovarian flow index at the baseline ultrasound scan are correlated with subsequent follicular response and may be a new indicator for predicting ovarian responsiveness in IVF treatment (Sattar 2005) The added value of ovarian volume and stromal blood flow, however, either individually or together, to AFC and endocrine markers, in the predictability of ovarian age has not been assessed in a multivariate module.
The challenge of any ovarian reserve tests, anyhow, lies in the possibility of identifying women with a reduced reproductive life span at such an early stage in their lives that adequate action can be taken. Basal endocrine levels and sonographic parameters, however, are usually considered to have low specificity and sensitivity when used both to predict low ovarian reserve in infertile women (Younis 2010) and to prognosticate distance from menopause. Although these simple tests have been extensively investigated in the past they have seldom been looked into in combination. On the contrary, improvement of tests for the identification of women with a reduced ovarian life span will probably come from combining endocrine and imaging evaluations.
- Conditions
- Infertility, Polycystic Ovary Syndrome, Premature Ovarian Failure (POF), Ovarian Cysts, Endometriosis
- Being tested
- OvAge assessment
- Keywords
- Ovarian reserve, Ovarian age, Fertility, Reproductive prognosis, Distance to menopause
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome, Primary Ovarian Insufficiency, Ovarian Cysts, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvAge assessmentOther
Basal serum anti-Mullerian hormone (AMH), Follicle-stimulating hormone (FSH) and Estradiol (E2), antral follicle count (AFC), ovarian volume, Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI) will be measured in all women between day 1 and day 4 of menstrual cycle. Evaluation can be repeated after every kind of intervention regarding ovaries, both medical or surgical. Evaluation can be repeated also at interval of 3-6-12 months in order to study the modification of ovarian age when time passes.
| Study group | Role | What they receive |
|---|---|---|
| OvAge assessment | Basal serum anti-Mullerian hormone (AMH), Follicle-stimulating hormone (FSH) and estradiol (E2), antral follicle count (AFC), ovarian volume, Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI) will be measured in all women between day 1 and day 4 of menstrual cycle Receives: Other: OvAge assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Age prediction
Reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance to menopause
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulvio Zullo, University Magna Graecia
- Investigators
- Fulvio Zullo, Study director, Magna Graecia University of CatanzaroRoberta Venturella, MD, Principal investigator, Magna Graecia University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086318
- Sponsor's protocol ID
- OvAge
- Acronym
- OvAge
- Status last verified
- Dec 2016
- First submitted
- 9 Mar 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Venturella R, Lico D, Sarica A, Falbo MP, Gulletta E, Morelli M, Zupi E, Cevenini G, Cannataro M, Zullo F. OvAge: a new methodology to quantify ovarian reserve combining clinical, biochemical and 3D-ultrasonographic parameters. J Ovarian Res. 2015 Apr 8;8:21. doi: 10.1186/s13048-015-0149-z.
PubMed 25881987Venturella R, Morelli M, Lico D, Di Cello A, Rocca M, Sacchinelli A, Mocciaro R, D'Alessandro P, Maiorana A, Gizzo S, Zullo F. Wide excision of soft tissues adjacent to the ovary and fallopian tube does not impair the ovarian reserve in women undergoing prophylactic bilateral salpingectomy: results from a randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1332-9. doi: 10.1016/j.fertnstert.2015.08.004. Epub 2015 Aug 31.
PubMed 26335129Venturella R, Lico D, Borelli M, Imbrogno MG, Cevenini G, Zupi E, Zullo F, Morelli M. 3 to 5 Years Later: Long-term Effects of Prophylactic Bilateral Salpingectomy on Ovarian Function. J Minim Invasive Gynecol. 2017 Jan 1;24(1):145-150. doi: 10.1016/j.jmig.2016.08.833. Epub 2016 Sep 13.
PubMed 27621194
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Algorithm to Predict Ovarian Age Combining Clinical, Biochemical and 3D-ultrasonographic Parameters: OvAge
- ClinicalTrials.gov ID
- NCT02086318
- Acronym / sponsor ID
- OvAge / OvAge
- Conditions
- Infertility, Polycystic Ovary Syndrome, Premature Ovarian Failure (POF), Ovarian Cysts, Endometriosis
- Keywords
- Ovarian reserve, Ovarian age, Fertility, Reproductive prognosis, Distance to menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Mar 2014 (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.
To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance to menopause following the guidelines of the Standards for Reporting of Diagnostic Accuracy initiative (STARD)
Detailed description
The normal process of reproductive aging varies considerably among women. This implies that some women remain highly fertile until the fifth decade of their life, whereas others face the loss of natural fertility already in their mid-thirties. Female reproductive aging seems to be largely based on age related changes in ovarian function. Decreasing numbers of follicles, coinciding with diminished oocyte quality, dictate the gradual changes in menstrual cycle regularity and monthly fecundity which inevitable evolution will be menopause. The mechanisms behind the observed gradual decline of the follicle pool and the reduced oocyte quality are far from being fully understood, although recent knowledge regarding the endocrine, paracrine, genetic, and metabolic factors involved has led to a better understanding of this immensely complex puzzle.
Within the context of normal female reproductive aging, as already outlined, large individual variation exists in the age at which the various reproductive events occur. This variation has major implications for the preventive management of age-related decreased fertility and general health risks associated with extremely early menopause in conditions such as POF. Moreover, distance from menopause is an important parameter which can lead clinician's choice in the appropriate timing for surgical treatment of benign gynecological pathologies.
Although chronological age is the most important predictor of physiological ovarian response to endogenous and exogenous Follicle-stimulating Hormone (FSH), both environmental and genetic factors contribute to biological ovarian ageing, so that chronological and biological age are not always equivalent. Among genetic factors able to determine age at which menopause will occur, the most important are the size of the initial oocyte stock, the proportion that undergoes atresia and the rate of initiation of follicles growth. It has been suggested, moreover, that certain single nucleotide polymorphisms (such as regarding FSH receptors genotype) also affect sensitivity to gonadotrophins and ovarian ageing [Alviggi 45]. Environmental factors such as diet, cigarette smoking, regimens of chemotherapy or radiotherapy, endometriosis or ovarian surgery may shorten the functional lifespan of a woman's ovaries too.
Even if the continuous follicles loss will only be recognized in the late stages by cycle irregularity, endocrine and ultrasound markers have emerged over the last decade that may express more accurately the follicle number decline over a long time period. Among endocrine parameters, the most studied and used in clinical practice are FSH, Estradiol (E2) and Anti-Mullerian Hormone (AMH).
Basal FSH, extensively studied over the past few decades, provides the most indirect marker of ovarian reserve. FSH levels increase with advancing age, by reducing the negative feedback on FSH release from the pituitary [broekm vecchio 10]. High FSH levels therefore represent small cohort size. To exclude the possibility that confounding factors, such as E2 levels greater than 50 pg/ml, suppress FSH secretion, this parameters have to be always evaluated together on menstrual cycle days 1-4.
In women with varying degrees of hypergonadotropism (ranging from imminent ovarian failure to full-blown POF), however, the better parameter to assess the extent of ovarian follicle depletion seems to be represented by AMH (Broekm 109). It is a dimeric glycoprotein with autocrine and paracrine actions in follicle development, exclusively produced by granulose cells of preantral (primary and secondary) and small antral follicles (2-7 mm in diameters). The number of small antral follicles is directly related to the total size of the primordial follicle pool (Broekm 68). With the decrease in the number of antral follicles with age, AMH serum levels also become diminished (Br 66, 95, 104) and will invariably become undetectable near menopause (Br 65). Recent studies have indeed suggested that AMH serum levels represent ovarian quantitative reserve (Br 105-107) and may provide an index of age at menopause.
Regarding ultrasound markers, several studies, recently, demonstrated that Antral Follicle Count (AFC), defined as the total number of antral follicles, sized 2-10 mm, present in both ovaries, represents a better marker than either chronological age or basal FSH for assessing the ovarian biological age [alviggi 89] and it has also been correlated with the occurrence of the menopausal transition (broekm 66), indicating that this parameter relates strongly with the quantitative aspects of ovarian reserve.
As for AFC, ovarian volume, measured by vaginal ultrasound, has been associated to the ovarian functional asset and also transvaginal ultrasound with the use of power Doppler is often used to evaluate the blood flow through the ovary in natural cycles. Several studies, moreover, have shown that ovarian flow index at the baseline ultrasound scan are correlated with subsequent follicular response and may be a new indicator for predicting ovarian responsiveness in IVF treatment (Sattar 2005) The added value of ovarian volume and stromal blood flow, however, either individually or together, to AFC and endocrine markers, in the predictability of ovarian age has not been assessed in a multivariate module.
The challenge of any ovarian reserve tests, anyhow, lies in the possibility of identifying women with a reduced reproductive life span at such an early stage in their lives that adequate action can be taken. Basal endocrine levels and sonographic parameters, however, are usually considered to have low specificity and sensitivity when used both to predict low ovarian reserve in infertile women (Younis 2010) and to prognosticate distance from menopause. Although these simple tests have been extensively investigated in the past they have seldom been looked into in combination. On the contrary, improvement of tests for the identification of women with a reduced ovarian life span will probably come from combining endocrine and imaging evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OvAge assessment | – | Other: OvAge assessmentBasal serum anti-Mullerian hormone (AMH), Follicle-stimulating hormone (FSH) and estradiol (E2), antral follicle count (AFC), ovarian volume, Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI) will be measured in all women between day 1 and day 4 of menstrual cycle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women
Key inclusion criteria (3 listed)
- Age between 18 and 55 years
- Consent to participate to the prospective study
- Regular menses at 22 to 35 day interval
Key exclusion criteria (4 listed)
- Estrogen or progestin-containing medications in the month before enrollment
- Gynecological malignancy
- Hypogonadotropic hypogonadism
- Assumption of drugs that can cause menstrual irregularity
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 |
|---|---|---|
| OvAge assessmentBasal serum anti-Mullerian hormone (AMH), Follicle-stimulating hormone (FSH) and Estradiol (E2), antral follicle count (AFC), ovarian volume, Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI) will be measured in all women between day 1 and day 4 of menstrual cycle. Evaluation can be repeated after every kind of intervention regarding ovaries, both medical or surgical. Evaluation can be repeated also at interval of 3-6-12 months in order to study the modification of ovarian age when time passes. | Other | OvAge assessment |
Primary outcome
Ovarian Age prediction
Time frame: One month
Reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance to menopause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Results publication: PubMed 25881987Venturella R, Lico D, Sarica A, Falbo MP, Gulletta E, Morelli M, Zupi E, Cevenini G, Cannataro M, Zullo F. OvAge: a new methodology to quantify ovarian reserve combining clinical, biochemical and 3D-ultrasonographic parameters. J Ovarian Res. 2015 Apr 8;8:21. doi: 10.1186/s13048-015-0149-z.
- Results publication: PubMed 26335129Venturella R, Morelli M, Lico D, Di Cello A, Rocca M, Sacchinelli A, Mocciaro R, D'Alessandro P, Maiorana A, Gizzo S, Zullo F. Wide excision of soft tissues adjacent to the ovary and fallopian tube does not impair the ovarian reserve in women undergoing prophylactic bilateral salpingectomy: results from a randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1332-9. doi: 10.1016/j.fertnstert.2015.08.004. Epub 2015 Aug 31.
- Results publication: PubMed 27621194Venturella R, Lico D, Borelli M, Imbrogno MG, Cevenini G, Zupi E, Zullo F, Morelli M. 3 to 5 Years Later: Long-term Effects of Prophylactic Bilateral Salpingectomy on Ovarian Function. J Minim Invasive Gynecol. 2017 Jan 1;24(1):145-150. doi: 10.1016/j.jmig.2016.08.833. Epub 2016 Sep 13.
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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.
Fulvio Zullo study director
Magna Graecia University of Catanzaro
Roberta Venturella, MD principal investigator
Magna Graecia University of Catanzaro
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 and Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
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 4 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 8 Dec 2016. 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 Italy. 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 Fulvio Zullo (39337947003, zullo@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Age prediction (time frame: One month). 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 NCT02086318, 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 8 Dec 2016.