Clinical trial NCT06572930: Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation
Official title: Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Stimulation
Keywords: ovarian response
stimulation protocols
stimulation monitoring
follicular stimulating hormone
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 39 years old, with 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 who is planned to undergo ovarian stimulation in a Gonadotropin hormone-releasing hormone (GnRH) antagonist protocol can be included.

Exclusion will be for women with hypogonadotropic hypogonadism, history of ovarian surgery, permanent ovarian cysts of any form, older than 39 years, abnormal thyroid function (TSH level outside the normal range), renal disease, elevated prolactin levels. intake of oral contraceptives 3 months before stimulation start and estradiol pretreatment will be excluded.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics
Study officials:
References:
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citation: Huber M, Hadziosmanovic N, Berglund L, Holte J. Using the ovarian sensitivity index to define poor, normal, and high response after controlled ovarian hyperstimulation in the long gonadotropin-releasing hormone-agonist protocol: suggestions for a new principle to solve an old problem. Fertil Steril. 2013 Nov;100(5):1270-6. doi: 10.1016/j.fertnstert.2013.06.049. Epub 2013 Aug 6.
citation: Jeppesen JV, Kristensen SG, Nielsen ME, Humaidan P, Dal Canto M, Fadini R, Schmidt KT, Ernst E, Yding Andersen C. LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles. J Clin Endocrinol Metab. 2012 Aug;97(8):E1524-31. doi: 10.1210/jc.2012-1427. Epub 2012 Jun 1.
citation: La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.
citation: Lawrenz B, Melado L, Digma S, Sibal J, Coughlan C, Andersen CY, Fatemi HM. Reintroducing serum FSH measurement during ovarian stimulation for ART. Reprod Biomed Online. 2022 Mar;44(3):548-556. doi: 10.1016/j.rbmo.2021.10.020. Epub 2021 Oct 31.
citation: Macklon NS, Stouffer RL, Giudice LC, Fauser BC. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev. 2006 Apr;27(2):170-207. doi: 10.1210/er.2005-0015. Epub 2006 Jan 24.