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NCT06572930·Not applicable·OBSERVATIONAL

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

CetrorelixOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

150

Locations

1

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Aug 27, 2024

  2. Study start

    Dec 16, 2024

  3. Primary completion

    Dec 1, 2026

  4. Study completion

    Dec 1, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

United Arab Emirates. Showing up to 24 locations stored in the fast local snapshot.

ART Fertility Clinics

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Publications

Results and literature.

PMID 16084880 ↗Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.PMID 23931964 ↗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.PMID 22659248 ↗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.PMID 24077980 ↗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.PMID 34973935 ↗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.PMID 16434510 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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