Status:
COMPLETED
Step Down FSH Approach and Late Follicular Phase in Progesterone Level
Lead Sponsor:
ART Fertility Clinics LLC
Collaborating Sponsors:
Merck Serono International SA
Conditions:
Progesterone Resistance
Eligibility:
FEMALE
18-40 years
Phase:
EARLY_PHASE1
Brief Summary
Step-down approach and late follicular phase progesterone level
Detailed Description
The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03356964
Start Date
November 23 2017
End Date
August 31 2020
Last Update
September 9 2020
Active Locations (1)
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1
IVI Middle East Fertilty Clinic
Abu Dhabi, United Arab Emirates