NCT02436538

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.6 years

First QC Date

May 4, 2015

Last Update Submit

December 3, 2016

Conditions

Infertility

Keywords

anti-Müllerian hormone (AMH)Mullerian anomaliesICSI

Outcome Measures

Primary Outcomes (1)

  • Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies

    2 years

Study Arms (1)

Mullerian duct anomalies

Anti Mullerian hormone level; Mullerian duct anomaly type

Other: Anti Mullerian hormone level; Mullerian duct anomaly type

Interventions

Anti Mullerian hormone level; Mullerian duct anomaly typeOTHER

Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels

Mullerian duct anomalies

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female undergoing intraCytoplasmic sperm injection for treatment of infertility

You may qualify if:

  • women with diagnosed mullerian anomlies whether clinically or through imaging

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Egyptian IVF-ET Center

Cairo, Maadi, 3 st,161 Hadayek el Maadi, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 23117477BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Anti-Mullerian Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Testicular HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Yahia El-fassial, M.D

    consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer Of obstetrics & Gynecology

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 7, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

EG(1)