Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04927676 |
| Other study ID # |
2802/2021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Medical University of Vienna |
| Contact |
Johannes Ott, MD, PhD |
| Phone |
+436504010485 |
| Email |
johannes.ott[@]meduniwien.ac.at |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The objective of this prospective cohort pilot study is to evaluate a complete hormonal
profile including AMH and antral follicle count in women with hypogonadotropic hypogonadism
(HH). As a secondary study objective, changes in these two parameters will be examined after
2 months of individual treatment. The data collected will be used to plan future studies in
the field.
The primary hypothesis is, that AMH levels which range from 0.5 ng/mL to 7.0 ng/mL and antral
follicular counts which range from 2 to 20 can be found in women with HH.
As secondary hypothesis the investigators assume that the AMH levels and the antral
follicular counts of women with HH do not change within two months of treatment with
estrogen-/gestagen-replacement therapy or no treatment, whereas AMH levels and antral
follicular counts will increase significantly after two months of pulsatile
gonadotropin-releasing hormone (GnRH) treatment.
Primary outcome parameters are serum level of AMH and the antral follicular count. Secondary
outcome parameters as for the descriptive analysis are: follicle stimulating hormone (FSH),
luteinizing hormone (LH), estradiol (either during amenorrhea or on cycle day 2-5 in the
course of treatment), sexual hormone binding globulin (SHBG), testosterone,
dehydroepiandrosterone-sulfate (DHEAS), results of a Dual Energy X-ray Absorptiometry (DEXA;
if performed), duration since last normal menstruation, patient's age and body mass index
(BMI).
The following parameters will be collected and included in the database. They do not require
additional effort on behalf of the patients. All data will be obtained using the
study-specific case report form and will be entered into a SPSS (IBM SPSS Statistics
Software) database in a semi-anonymized manner: Patient's age, Body mass index, duration
since last normal menstruation, FSH, LH, Estradiol, SHBG, Testosterone, DHEAS, DEXA results,
AMH, Antral follicular count. Data acquisition will be conducted to give an exact
characterization of the patient population to allow a comparison with the published
literature. All taken blood samples are performed as part of the clinical routine at the
Clinical Institute of Laboratory Medicine at Vienna General Hospital.
The study is designed as a pilot study. This is due to the lack of sufficient literature on
this topic. Fifty women with HH and secondary amenorrhea will be included.
Potential participants are informed about the procedure, clinical relevance and the balance
of risk and benefits incurred through study participation. Patients willing to participate
will express this through written affirmation (a "consent form").
All above mentioned data are numerical data and will be reported as mean and standard
deviations. Differences between different treatment groups will be tested using unpaired
t-tests, whereas differences within groups (baseline to follow-up examinations) will be
tested using paired t-tests. Statistical analyses were performed with SPSS 26.0. P-values
<0.05 will be considered statistically significant.
Extreme values will be double-checked. In addition, random checks by two independent
investigators will be conducted to ensure the accuracy of the data.
In this prospective study, no further data acquisitions, follow-up examinations or surveys
will be necessary. Accordingly, if patients would be undergoing the described interventions
(blood retrieval, DEXA analysis) independent of their choice to participate, this should not
shift cost or risk for them. The analysis and publication of the data will be done with
patient de-identification.
The decision on how to proceed after the initial diagnosis is made in the course of routine
clinical practice, after the medical team in charge of the patient has provided precise
information on the advantages and risks of the respective procedures. Participation in the
study therefore has no influence on the type of further procedure or therapy.
The study is conducted as independent official research. The company "Ferring Arzneimittel
GmbH (Gesellschaft mit beschränkter Haftung)" is supporting the conduct of the study with
3,000 euros. The company produces the preparation "LutreLef", which is administered to some
patients as part of the clinical routine with the pump system "LutrePulse".
