Cohort Study to Assess the Impact of CYP2D6 Genotype on the Efficacy ofClomiphene

• Conditions: N97.9; Female infertility, unspecified

• Registration Number: DRKS00010070
• Lead Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-17
• Study Completion: 2017-03-31
• Results First Posted: 2020-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 161

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the therapeutic efficacy of clomiphene in relation to its metabolic profile and the CYP2D6 genotype.<br>Primary endpoint variables:<br>1. Measurement of growing follicles by transvaginal ultrasound (largest follicle diameter).<br>2. Number of mature follicles (mean diameter = 18 mm)

Secondary Outcome Measures

Name	Time	Method
1. Investigation of further parameters for the efficacy of clomiphene in relation to CYP2D6 genotype:<br>- sex steroid hormone levels (LH, FSH, estradiol, progesterone, testosterone, AMH)<br>- Number of follicles > 15 mm<br>- height of the lining of the Uterus<br>- highest clomiphene dose / number of therapy clycles<br>2. Clomiphene and metabolites blood levels<br>