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

February 20, 2025 updated by: ART Fertility Clinics LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2406-ABU-006-BA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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