Hormones in Hypogonadotropic Hypogonadism

NCT04927676 | Unknown DMC

• 1 other identifier: 2802/2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Therefore, the main objective of this prospective pilot study is to evaluate a complete hormonal profile in women with hypogonadotropic hypogonadism, including anti-mullerian hormone (AMH) and antral follicle count. Changes in this regard will be evaluated after 2 months of individual treatment.

Conditions

AMH; Hypogonadism, Hypogonadotropic; Follicle Cyst

Outcome Measures

Primary Outcomes (2)

• AMH

  Evaluation of a complete hormone profile including AMH in women with HH

  2 months

• antral follicle count

  Evaluation of the antral follicle count in women with HH

  2 months

Secondary Outcomes (2)

• AMH after 2 months

  2 months

• Antral follicle count after 2 months

  2 months

Interventions

Blood sample DIAGNOSTIC_TEST

Blood samples were taken from a peripheral vein as part of clinical routine. Subsequently, a hormone status is determined.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HH and secondary amenorrhea presenting to the Department of Obstetrics and Gynecology, Medical University of Vienna. The target number of cases for this pilot study is 50 patients.

You may qualify if:

• Patient with HH and secondary amenorrhea. HH is defined as absence of spontaneous menstruation for ≥6 months, no abrupt menstrual bleeding after progesterone therapy, and normal or low serum FSH and LH levels.
• The patient gave written informed consent to the study after receiving detailed information and education from medical contributors at the Department of Obstetrics and Gynecology, Medical University of Vienna.
• Age between \>18 and \<35 years.

You may not qualify if:

• Latent or manifest hypothyroidism (TSH \>4 micromole/milliliter) or current thyroid hormone replacement therapy.
• No existing informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead
• Ferring Arzneimittel GmbH: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples taken as part of routine clinical practice, including hormone status: AMH, FSH, LH, Estradiol, SHBG, DHEAS, Testosterone

MeSH Terms

Conditions

Hypogonadism; Follicular Cyst

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Johannes Ott, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Ott, MD, PhD

CONTACT

+436504010485; johannes.ott@meduniwien.ac.at

Klara Beitl, MD

CONTACT

+4369912661163; klara.beitl@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant Physician

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 16, 2021
• Study Start: April 2, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)