Correlation Between Serum Anti-Müllerian Hormone & Müller... | NCT02436538

Studies
Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility

NCT02436538

Sponsor

Ahmed M.Kamel

Status

Completed

Last Update Posted

Dec 6, 2016Estimated

Enrollment

226Actual

Phase

Not provided

Conditions

Infertility

Interventions

Anti Mullerian hormone level; Mullerian duct anomaly type

Countries

Egypt

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

Dec 2016

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

Apr 2015

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

May 6, 2015

First Posted Date

May 7, 2015Estimated

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

Dec 3, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Name	Class
The Egyptian IVF-ET Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis

Detailed Description

Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done.

Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.

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

No data available

No data is available for this block.

Enrollment

226Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mullerian duct anomalies		Anti Mullerian hormone level; Mullerian duct anomaly type	Other: Anti Mullerian hormone level; Mullerian duct anomaly type

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti Mullerian hormone level; Mullerian duct anomaly type	Other	Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels	Mullerian duct anomalies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with diagnosed mullerian anomlies whether clinically or through imaging

Exclusion Criteria:

previous ovarian surgery
ovarian drilling
polycystic ovarian syndrome (PCOs).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

female undergoing intraCytoplasmic sperm injection for treatment of infertility

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yahia El-fassial, M.D	consultant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Egyptian IVF-ET Center		Cairo	Maadi	3 st,161 Hadayek el Maadi	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23117477	Background	Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Mullerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. Epub 2012 Nov 2.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D013735	Testicular Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists