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

NCT06572930 | Recruiting

• 1 other identifier: 2406-ABU-006-BA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Stimulation

Keywords

ovarian response; stimulation protocols; stimulation monitoring; follicular stimulating hormone

Outcome Measures

Primary Outcomes (1)

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

  serum FSH levels during ovarian stimulation

  1 year

Study Arms (1)

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.

Drug: Gonal-f (gonadotropin)

Interventions

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.

FSH Monitoring Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics

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

RECRUITING

Related Publications (6)

• 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: 16084880 BACKGROUND

• 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: 23931964 BACKGROUND

• 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: 22659248 BACKGROUND

• 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: 24077980 BACKGROUND

• 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: 34973935 BACKGROUND

• 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.

  PMID: 16434510 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests, urine and follicular fluid for hormonal assessment

MeSH Terms

Interventions

follitropin alfa; Gonadotropins

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Jonalyn Edades

CONTACT

+971526408688; jonalyn.edades@artfertilityclinics.com

Baris Ata, MD

CONTACT

+971504374824; baris.ata@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 27, 2024
• Study Start: December 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)