Step Down FSH Approach and Late Follicular Phase in Progesterone Level

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

Step-down approach and late follicular phase progesterone level

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ART Fertility Clinics LLC; IVI Middle East Fertility Clinic
• Collaborator: Merck Serono International SA
• Treatments: Follicle Stimulating Hormone; Hormones; Progesterone

Criteria

Inclusion Criteria:

• Primary / secondary infertility with the indication for IVF/ICSI

• Patients age 18 - 40 years

• 60 kg up to and including 90 kg

• BMI of 18-32 kg/m2

• Menstrual cycle length of 24-35 days

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion criteria:

• presence or history of an endocrine abnormality

• abnormal outcome of blood biochemistry or hematology

• relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment

• history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)

• History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)

• ovarian reserve parameter, indicating the risk of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) (14)