Step Down FSH Approach and Late Follicular Phase in Progesterone Level

Study Overview
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Brief Summary
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Step-down approach and late follicular phase progesterone level

Detailed Description
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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.

Official Title
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Impact of Step-down Approach During Late Follicular Phase in Recombinant FSH-stimulation Dosage for IVF on Progesterone Level on the Day of Final Oocyte Maturation

Conditions
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Progesterone Resistance

Intervention / Treatment
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* Drug: follicle stimulating hormone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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). | Drug: follicle stimulating hormone<br>* Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged<br>* Other names: Gonal-F;|
| Experimental: Study group<br>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). | Drug: follicle stimulating hormone<br>* Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged<br>* Other names: Gonal-F;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of dose reduction in recFSH for IVF on the progesterone level. | Whether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels. | 1year and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial receptivity progesterone elevation