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NCT Number: NCT06572930

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

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.

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

ART Fertility Clinics

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location status: Recruiting

Location contact

Jonalyn Edades, Nursing

CONTACT

[email protected]

+971526408688

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonal-f (gonadotropin)

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.

Primary outcomes

  1. Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.

    Time frame: 1 year

    serum FSH levels during ovarian stimulation

Study contacts

Contact information is provided by the study sponsor or research team.

Baris Ata, MD

CONTACT

[email protected]

+971504374824

Jonalyn Edades

CONTACT

[email protected]

+971526408688

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders

Acronym: FSH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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