NCT02086318

Brief 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 to menopause following the guidelines of the Standards for Reporting of Diagnostic Accuracy initiative (STARD)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

6.4 years

First QC Date

March 9, 2014

Last Update Submit

December 7, 2016

Conditions

InfertilityPolycystic Ovary SyndromePremature Ovarian Failure (POF)Ovarian CystsEndometriosis

Keywords

Ovarian reserveOvarian ageFertilityReproductive prognosisDistance to menopause

Outcome Measures

Primary Outcomes (1)

  • Ovarian Age prediction

    Reliability of a multimodal diagnostic evaluation of ovarian age in term of both reproductive prognosis and distance to menopause

    One month

Study Arms (1)

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

Other: OvAge assessment

Interventions

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.

OvAge assessment

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women

You may qualify if:

  • Age between 18 and 55 years
  • Consent to participate to the prospective study
  • Regular menses at 22 to 35 day interval

You may not qualify if:

  • Estrogen or progestin-containing medications in the month before enrollment
  • Gynecological malignancy
  • Hypogonadotropic hypogonadism
  • Assumption of drugs that can cause menstrual irregularity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25881987RESULT

  • Venturella 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.

    PMID: 26335129RESULT

  • Venturella 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.

    PMID: 27621194RESULT

MeSH Terms

Conditions

InfertilityPolycystic Ovary SyndromePrimary Ovarian InsufficiencyOvarian CystsEndometriosis

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Study Officials

  • Fulvio Zullo

    Magna Graecia University of Catanzaro

    STUDY DIRECTOR

  • Roberta Venturella, MD

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Zullo

CONTACT

39337947003zullo@unicz.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Obstetric Gynecology

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 13, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

IT(1)