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follicle stimulating hormone

Phase 1

Progesterone Resistance | Small molecule | Other |Merck & Company, Inc.|Last Updated: Sep 9, 2020

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

follicle stimulating hormone · 1 trial · 1 indication

Early Phase 1 1
NCT03356964Step Down FSH Approach and Late Follicular Phase in Progesterone LevelProgesterone Resistance
COMPLETED127 Analytics
EARLY_PHASE1COMPLETED
Step Down FSH Approach and Late Follicular Phase in Progesterone Level
Progesterone ResistanceUnlock trial analytics

Study Endpoints

Primary Endpoints

Impact of dose reduction in recFSH for IVF on the progesterone level.
1year and 6 months

Whether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Control groupACTIVE_COMPARATORFollicle 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).
Study groupEXPERIMENTALFollicle 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).

Interventions

NameTypeDescription
follicle stimulating hormoneDRUGFollicle 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
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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 exclu...

Countries:United Arab Emirates
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Frequently asked questions about follicle stimulating hormone

What is follicle stimulating hormone used for?

Follicle stimulating hormone is being studied for use in progesterone resistance. It is an investigational small molecule in Phase 1 clinical development, being evaluated in a completed early Phase 1 trial that enrolled 127 participants.

Who makes follicle stimulating hormone?

Merck & Company, Inc. (NYSE: MRK) is developing follicle stimulating hormone. The company is conducting clinical research on this investigational small molecule for progesterone resistance.

What phase is follicle stimulating hormone in?

Follicle stimulating hormone is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed an early Phase 1 trial. The study was a randomized, active-controlled trial that enrolled 127 participants.

What clinical trials is follicle stimulating hormone in?

Follicle stimulating hormone has one completed clinical trial, NCT03356964, titled "Step Down FSH Approach and Late Follicular Phase in Progesterone Level." This early Phase 1 study enrolled 127 female participants in the United Arab Emirates and included healthy volunteers.

Is follicle stimulating hormone the same as FSH?

Follicle stimulating hormone is commonly abbreviated as FSH. In the clinical trial NCT03356964, the study title refers to the "Step Down FSH Approach," indicating that FSH is the same agent as follicle stimulating hormone.