Step Down FSH Approach and Late Follicular Phase in Progesterone Level

Early Phase 1

Completed

• Conditions: Progesterone Resistance
• Interventions: Drug: follicle stimulating hormone

• Registration Number: NCT03356964
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2017-11-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-29
• Primary Completion: 2020-02-12
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	follicle stimulating hormone	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).
Study group	follicle stimulating hormone	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IVI Middle East Fertilty Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates