Role of Inhibin A as Biomarker for Ovarian Response for I... | NCT03607409

Studies
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment

NCT03607409

Sponsor

ART Fertility Clinics LLC

Status

Completed

Last Update Posted

Aug 8, 2019Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2018Actual

Primary Completion Date

Jan 29, 2019Actual

Completion Date

Jul 4, 2019Actual

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 8, 2019Actual

Name	Class
Ansh Labs	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol

Detailed Description

Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of mature oocytes	Patients undergoing ovarian stimulation with gonadotropins	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.

Exclusion Criteria:

Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Patients undergoing ovarian stimulation for IVF treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Lawrenz, PhD	ART Fertility Clinics LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVI Middle East Fertilty Clinic		Abu Dhabi		60202	United Arab Emirates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10999828	Background	Schneyer AL, Fujiwara T, Fox J, Welt CK, Adams J, Messerlian GM, Taylor AE. Dynamic changes in the intrafollicular inhibin/activin/follistatin axis during human follicular development: relationship to circulating hormone concentrations. J Clin Endocrinol Metab. 2000 Sep;85(9):3319-30. doi: 10.1210/jcem.85.9.6767.
15757856	Background

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases