Fertility and sexual function in people with congenital adrenal hyperplasia
Channelling Fertility And Sexual Function In Congenital Adrenal Hyperplasia. CALLIOPE: An Observational, Longitudinal Pilot Study
This study will test whether new CAH treatments improve fertility and sexual health in adults with congenital adrenal hyperplasia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT07099456 on ClinicalTrials.gov |
What this trial studies
CALLIOPE is a multicenter observational study enrolling adult men (18–65) and pre‑menopausal women (18–55) with confirmed CAH to collect clinical, biochemical and reproductive data. Investigators will use standardized LC‑MS/MS hormone assays, semen analyses for men, and validated questionnaires and exams to document sexual function and fertility markers. The study compares outcomes across contemporary pharmacologic management strategies to explore associations between treatment patterns and reproductive health. Common exclusion criteria (for example major organ failure, other steroid-requiring conditions, disruptive psychiatric disease, or hormonal-interfering medications) are applied to reduce confounding.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of CAH—men aged 18–65 and pre‑menopausal women aged 18–55—who are medically stable and not taking interfering hormonal therapies are ideal candidates.
Not a fit: People who are postmenopausal, have BMI >40 kg/m2, require chronic steroids for other conditions, have severe liver or kidney disease, active substance abuse, uncontrolled thyroid or psychiatric disease, or unstable use of hormonal contraceptives are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose treatments that improve fertility and sexual health for people with CAH.
How similar studies have performed: Anecdotal reports and small recent trials have suggested improvements in sperm counts and menstrual regularity with novel CAH therapies, but robust prospective evidence on fertility outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, males in the age range 18-65 years and pre-menopausal females in the age range 18-55 years; * a known/new diagnosis of CAH. Exclusion Criteria: * BMI \> 40 Kg/m2; * Any other concomitant condition requiring steroid treatment; * Severe liver and/or kidney disease; * Thyroid dysfunctions (overt hyperthyroidism and hypothyroidism); * Malignant neoplasms; * Drug and alcohol abuse; * Use of drugs acting on hormonal levels (e.g. antiandrogens); * Psychiatric diseases; * Postmenopausal women; * Women taking combined oral contraceptive pill (women) or other contraceptives will require stability for at least 6 months.
Where this trial is running
Rome, Italy
- Department of Experimental Medicine, Sapienza University of Rome — Rome, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea M Isidori, MD, PhD, FRCP
- Email: andrea.isidori@uniroma1.it
- Phone: +39 0649970540
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.