Step Down FSH Approach and Late Follicular Phase in Progesterone Level

ART Fertility Clinics LLC

Status and phase: Completed; Early Phase 1

Conditions: Progesterone Resistance

Treatments: Drug: follicle stimulating hormone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03356964

1612-ABU-084-HF

Details and patient eligibility

About

Step-down approach and late follicular phase progesterone level

Full 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 12.5IU.

It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.

Enrollment: 127 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

Control group

Active Comparator group

Description:

Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (13). The stimulation dosage will remain unchanged until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).

Treatment:

Drug: follicle stimulating hormone

Study group

Experimental group

Description:

Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (LaMarca et al.). As soon as ≥ 3 follicle of a size of 14mm are seen, the stimulation dosage will be reduced daily by 12.5 IU recFSH until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).

Treatment:

Drug: follicle stimulating hormone