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Step Down FSH Approach and Late Follicular Phase in Progesterone Level

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03356964
Acronym
FSH
Enrollment
127
Registered
2017-11-29
Start date
2017-11-23
Completion date
2020-08-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progesterone Resistance

Keywords

endometrial receptivity progesterone elevation

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 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.

Interventions

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

Sponsors

Merck Serono International SA
CollaboratorINDUSTRY
ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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:

Design outcomes

Primary

MeasureTime frameDescription
Impact of dose reduction in recFSH for IVF on the progesterone level.1year and 6 monthsWhether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels.

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026