Conditions that can impair fertility Other
Conditions
Interventions
Healthy male and female participants with normal or reduced fertility will be identified from clinics and newspaper advertisements. Potential participants will be offered an invitation to a screening
we have already administered these identical doses during our previous studies and no adverse effects have been reported.
The gonadotrophin-releasing hormone (GnRH) test has been used safely and rout
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 16 years 2. Ability to give informed consent 3. Adult participants will be recruited with no known problems with reproductive function ("normal fertility") 3. Adult participants will be recruited with previous problems with reproductive function ("reduced fertility") 4. Availability to attend hospital visits during weekdays for study visits.
Exclusion criteria
Exclusion criteria: 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the reproductive hormone levels or potentially cause harm to the volunteer 2. Pregnancy or breastfeeding 3. History of hypersensitivity to any of the components of the infusions 4. Treatment with an investigational drug within the preceding 2 months 5. Volunteers who have or intend to donate blood or blood products within three months before or following study completion 6. Volunteers with poor venous access. 7. A history of alcoholism or substance abuse within the preceding 5 years 8. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 9. A history of cancer 10. Volunteers with a medical or psychological condition that would impair their ability to participate reliably in the study or give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Luteinising hormone (LH) levels measured using chemiluminescent assay over 8hrs 2. LH pulsatility measured over 8hrs by blinded deconvolution analysis 2. Follicle-stimulating hormone levels measured using chemiluminescent assay over 8hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Testosterone levels measured using chemiluminescent assay over 8hrs 2. Oestrogen levels measured using chemiluminescent assay over 8hrs 3. Progesterone levels measured using chemiluminescent assay over 8hrs | — |
Countries
England, United Kingdom
Outcome results
None listed