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

Infertility Clinical Trial

Official title:

Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436538
• Other study ID #: 13546
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: December 3, 2016
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• women with diagnosed mullerian anomlies whether clinically or through imaging

Exclusion Criteria:

• previous ovarian surgery

• ovarian drilling

• polycystic ovarian syndrome (PCOs).

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Infertility

Intervention

Other:
• Anti Mullerian hormone level; Mullerian duct anomaly type
Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels

Locations

Country	Name	City	State
Egypt	The Egyptian IVF-ET Center	Cairo	Maadi

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed M.Kamel	The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Müllerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies		2 years	No