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Clinical Trials/CTRI/2025/08/093734
CTRI/2025/08/093734Not yet recruitingNot Applicable

Serum AMH level- a potential biomarker for diagnosing women with PCOS among regional population

Dr Sandhya Babu1 site in 1 country137 target enrollmentStarted: September 15, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
137
Locations
1
Primary Endpoint
Serum AMH level- a diagnostic tool in diagnosing PCOS

Study Overview

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among women in the age group 15 to 45 years. The prevalence of this syndrome ranges from 4% to 22.5% depending on ethnicity, increasing up to 52% among South Asian women. PCOS is morphologically defined as the presence of more follicles, especially in small preantral and antral follicles of size up to 8mm, which are actually the source of serum AMH. Due to mitotic arrest, the follicles keep on secreting the hormone, which in turn reflects the condition. Serum AMH can be a reliable, non-invasive, and affordable test that aids us in diagnosing PCOS, which helps in planning for further management of infertility. AMH is more reliable than antral follicular count from ultrasonography as AMH is a reflection of all the follicles in active and AFC is not superior to AMH. Our study mainly aims in detecting the serum AMH level pertaining to the regional population to predict PCOS among infertile population.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Women fulfilling Rotterdam’s criteria at or above 20 years of age.

Exclusion Criteria

  • Women who underwent any gynaecological procedure (ovarian drilling, cystectomy, etc.).
  • Women who are already on management for PCOS, like ovarian drilling, infertility treatment, etc.
  • Women with other gynaecological complaints like adenomyosis, fibroid or severe endometriosis.

Outcomes

Primary Outcomes

Serum AMH level- a diagnostic tool in diagnosing PCOS

Time Frame: 12 MONTHS

Secondary Outcomes

  • To compare Serum AMH levels with or without hirsutism(To compare Serum AMH levels with normal and abnormal sonological findings)

Investigators

Sponsor
Dr Sandhya Babu
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Grace Mano R

Sandhya Hospital

Study Sites (1)

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