Clinical trial NCT03106272: Evaluating the AMH Levels During Natural Cycle
Official title: Anti-Mullerian Hormone Dynamics During Natural Cycle Using Automated Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-Mullerian Hormone Resistance
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women with regular menstrual cycles.

Brief summary: To describe AMH serum levels dynamics during natural cycle using an automated assay.

Detailed description: The potential benefit would be using an automated assay for AMH, the dynamics of serum levels during the natural cycle and to check the inter-cycle variations.

Because of the many clinical decisions that are based on AMH levels alone the results of this study could bring reassurance to the continuous use of AMH in daily practice. More importantly, no studies to date have been performed on the newer automated assays evaluating variability of AMH levels.

Eligibility criteria: Inclusion Criteria:

* Women with written informed consent.
* Women between ≥ 18 and ≤ 37 years of age.
* BMI between 18 and 28.
* Normal physical examination and pelvic exam.

Exclusion Criteria:

* Pregnancy.
* Breastfeeding.
* History of any disease/iatrogenic intervention which could have had an impact on the ovarian reserve (e.g. ovarian surgery, chemotherapy, radiation of the pelvis, endometriosis)
* Intake of OCP for the two last menstrual cycles.

Primary outcomes:
measure: AMH serum levels dynamic
timeFrame: 9months
Secondary outcomes:
measure: Inter-cycle AMH variations
timeFrame: 9months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: IVI Middle East Fertility Clinic LLC
name: Human Fatemi, Medical D.
role: PRINCIPAL_INVESTIGATOR
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