Evaluating hormonal profiles in women with hypogonadotropic hypogonadism
Hormone Profile in Women With Hypogonadotropic Hypogonadism - a Prospective Pilot Study
Medical University of Vienna · NCT04927676
This study is trying to see how different treatments affect hormone levels and egg development in women with hypogonadotropic hypogonadism over two months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04927676 on ClinicalTrials.gov |
What this trial studies
This prospective pilot study aims to assess the complete hormonal profile, including anti-mullerian hormone (AMH) levels and antral follicle count, in women diagnosed with hypogonadotropic hypogonadism (HH). Participants will undergo individual treatment, and changes in hormonal parameters will be monitored over a two-month period. The study seeks to establish baseline data that can inform future research in this area, focusing on the effects of different treatment modalities on hormonal levels and follicular development.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 35 with hypogonadotropic hypogonadism and secondary amenorrhea.
Not a fit: Patients with thyroid disorders or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatments for women with hypogonadotropic hypogonadism, potentially improving fertility outcomes.
How similar studies have performed: While there have been studies on hormonal profiles in related conditions, this specific approach focusing on HH and the effects of pulsatile GnRH treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Latent or manifest hypothyroidism (TSH \>4 micromole/milliliter) or current thyroid hormone replacement therapy. * No existing informed consent
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Principal investigator: Johannes Ott, MD, PhD — Medical University of Vienna
- Study coordinator: Johannes Ott, MD, PhD
- Email: johannes.ott@meduniwien.ac.at
- Phone: +436504010485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AMH, Hypogonadism, Hypogonadotropic, Follicle Cyst