Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation

Recruiting

• Conditions: Ovarian Stimulation
• Interventions: Drug: Gonal-f (gonadotropin)

• Registration Number: NCT06572930
• Lead Sponsor: ART Fertility Clinics LLC

Brief Summary

This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.

Detailed Description

Ovarian stimulation typically uses transvaginal ultrasound to monitor follicle growth and endometrial condition, with some clinics also tracking serum estradiol and progesterone levels, but often neglecting serum Follicle Stimulation Hormone (FSH). FSH is essential for follicle development, yet its levels can vary widely among women receiving the same dose due to factors like body weight, renal function, and ovarian reserve.

This study aims to identify a minimum effective FSH threshold that ensures optimal follicular growth while avoiding excess administration.

Study Timeline

• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-27
• Study Start: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• regular 21 - 35 days cycles
• BMI between 19 - 30 kg/m2
• serum AMH level between 1.5 to 3 ng/ml
• a total antral follicle count between 10 to 24
• endogenous early follicular phase serum FSH level <10 IU/L
• normal glomerular filtration rate

Exclusion Criteria

• hypogonadotropic hypogonadism
• history of ovarian surgery
• permanent ovarian cysts of any form
• older than 39 years
• abnormal thyroid stimulating hormone (TSH)
• renal disease
• elevated prolactin levels
• intake of oral contraceptives 3 months before stimulation start and estradiol pretreatment will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FSH Monitoring Group	Gonal-f (gonadotropin)	Women undergoing ovarian stimulation will be given preselected constant gonadotropin dosage and an association between serum FSH (follicular stimulating hormone) levels during stimulation and response will be assessed. Blood samples will be taken (along with clinical standard routine) on day 2/3 of cycle, day 5 / 8 and 10 of stimulation and on the day of trigger (DoT). Urine samples will be taken additionally. Final oocyte maturation will be triggered with 250 mcg recombinant human Choriogonadotropin and 0.2 mg Decapeptyl as soon as \>2 follicles reach 17 mm diameter. Women who have more than 30 follicles ≥12 mm and or serum estradiol levels above\>5000 pg/ml on the day of trigger will only be triggered with Decapeptyl. OPU (oocyte pick up) will be 36 h after trigger. On the day of oocyte collection (OPU), follicular fluid from the largest follicle will be checked for FSH level after the cumulus oocyte complex is removed.

Primary Outcome Measures

Name	Time	Method
Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.	1 year	serum FSH levels during ovarian stimulation

Trial Locations

Locations (1)

ART Fertility Clinics; 🇦🇪 Abu Dhabi, United Arab Emirates