Clinical trial NCT05330130: Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells
Official title: Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Function Insufficiency
Fertility Issues
Infertility,Female
Infertility
Keywords: Ovarian stimulation
Granulosa cells
Follicle Stimulating Hormone Receptor
Luteinising Hormone Receptor
Elevated progesterone
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
Collaborators: name: Organon and Co
First posted: 2022-04-15
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.

Detailed description: This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.

Eligibility criteria: Inclusion Criteria:

* Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
* BMI of 18-32 kg/m2
* Regular menstrual cycles with a length of 24-35 days
* Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)

Exclusion Criteria:

* Occurrence of ovarian hyperstimulation syndrome (OHSS)
* Occurrence of poor ovarian response (AFC \< 5 and AMH \< 0,5ng/ml) in previous ovarian stimulation treatment (20)
* Polycystic ovary syndrome (PCOS) (21)

Primary outcomes:
measure: Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle
timeFrame: 5 days
measure: Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle
timeFrame: 1 day
measure: Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle
timeFrame: 1 day
measure: Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU
timeFrame: 1 day
Secondary outcomes:
measure: Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of LH hormone in the blood, on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of E2 hormone in the blood, on the day of OPU
timeFrame: 1 day
measure: Level of P4 hormone in the blood, on the day of OPU
timeFrame: 1 day
measure: Level of FSH hormone in the blood, on the day of OPU
timeFrame: 1 day
measure: Level of LH hormone in the blood, on the day of OPU
timeFrame: 1 day
measure: Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
timeFrame: 5 days
measure: Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
timeFrame: 1 day
measure: Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
timeFrame: 1 day
measure: Level of E2 hormone in the follicular fluid of follicles aspirated during OPU
timeFrame: 1 day
measure: Level of P4 hormone in the follicular fluid of follicles aspirated during OPU
timeFrame: 1 day
measure: Level of FSH hormone in the follicular fluid of follicles aspirated during OPU
timeFrame: 1 day
measure: Level of LH hormone in the follicular fluid of follicles aspirated during OPU
timeFrame: 1 day
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
affiliation: ART Fertility Clinics LLC
name: Barbara Lawrenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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