N97.9
Conditions
Interventions
Group 1: Women, who are foreseen for therapy with clomiphene, will be asked for a blood sample for genotyping (2 x 2,7 ml EDTA blood). Furthermore, a blood withdrawal is planned during individual clom
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to study entry including informed consent for genetic Research 2. Aged 18 to 40 years 3. BMI 18.5 kg/m² - 26 kg/m² 4. Minimum of one planned or done clomiphene therapy cycle
Exclusion criteria
Exclusion criteria: 1. Concomitant treatment with other ovulation inducing medication (e.g FSH, LHRH-analogue; induction of ovulation by hCG is allowed) 2. Unwillingness to provide informed consent of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the therapeutic efficacy of clomiphene in relation to its metabolic profile and the CYP2D6 genotype. Primary endpoint variables: 1. Measurement of growing follicles by transvaginal ultrasound (largest follicle diameter). 2. Number of mature follicles (mean diameter = 18 mm) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Investigation of further parameters for the efficacy of clomiphene in relation to CYP2D6 genotype: - sex steroid hormone levels (LH, FSH, estradiol, progesterone, testosterone, AMH) - Number of follicles > 15 mm - height of the lining of the Uterus - highest clomiphene dose / number of therapy clycles 2. Clomiphene and metabolites blood levels | — |
Countries
Germany
Contacts
Public ContactSvitlana Igel
Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie
Outcome results
None listed