Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04927676
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2021-05-31
Brief Title:
Hormones in Hypogonadotropic Hypogonadism
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Hormone Profile in Women With Hypogonadotropic Hypogonadism - a Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 05 ngmL to 70 ngmL 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 patients 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 Patients 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 260 P-values 005 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 3000 euros The company produces the preparation LutreLef which is administered to some patients as part of the clinical routine with the pump system LutrePulse
The primary hypothesis is that AMH levels which range from 05 ngmL to 70 ngmL 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 patients 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 Patients 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 260 P-values 005 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 3000 euros The company produces the preparation LutreLef which is administered to some patients as part of the clinical routine with the pump system LutrePulse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None