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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-16

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells

NCT05330130

Ovarian Function Insufficiency Fertility Issues Infertility,Female +1 more

COMPLETED PHASE1

Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

NCT02915900

Infertility

COMPLETED NA

Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction

NCT01081626

Ovulation Induction

COMPLETED PHASE4

Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles

NCT02310919

Infertility

COMPLETED PHASE3

Step Down FSH Approach and Late Follicular Phase in Progesterone Level

NCT03356964

Progesterone Resistance

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FSH Monitoring Group

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.

Gonal-f (gonadotropin)

Intervention Type DRUG

Women will be given 300 IU Gonal-F daily from cycle day 2 or 3. Gonal F will be injected at 8 pm daily. They will all receive cetrorelix acetate 250 mcg/day (Cetrotide) subcutaneously from stimulation day 5 onwards until and including the trigger day. Cetrotide will be administered at 08:00 am.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gonal-f (gonadotropin)

Women will be given 300 IU Gonal-F daily from cycle day 2 or 3. Gonal F will be injected at 8 pm daily. They will all receive cetrorelix acetate 250 mcg/day (Cetrotide) subcutaneously from stimulation day 5 onwards until and including the trigger day. Cetrotide will be administered at 08:00 am.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes