Ovarian StimulationFSHNCT06572930
Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation
An observational study of Ovarian Stimulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- Gonal-f (gonadotropin)
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 16 Dec 2024to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics
Abu Dhabi, Abu Dhabi Emirate, 60202
Jonalyn Edades, Nursing, +971526408688, jonalyn.edades@artfertilityclinics.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Stimulation
- Being tested
- Gonal-f (gonadotropin)
- Keywords
- ovarian response, stimulation protocols, stimulation monitoring, follicular stimulating hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gonal-f (gonadotropin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.
serum FSH levels during ovarian stimulation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start16 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572930
- Sponsor's protocol ID
- 2406-ABU-006-BA
- Acronym
- FSH
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Publications
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.
PubMed 16084880Huber 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.
PubMed 23931964Jeppesen 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.
PubMed 22659248La 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.
PubMed 24077980Lawrenz 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.
PubMed 34973935Macklon 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.
PubMed 16434510
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders
- ClinicalTrials.gov ID
- NCT06572930
- Acronym / sponsor ID
- FSH / 2406-ABU-006-BA
- Conditions
- Ovarian Stimulation
- Keywords
- ovarian response, stimulation protocols, stimulation monitoring, follicular stimulating hormone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSH Monitoring Group | – | Drug: Gonal-f (gonadotropin)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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- hypogonadotropic hypogonadism
- history of ovarian surgery
- permanent ovarian cysts of any form
- older than 39 years
- abnormal thyroid stimulating hormone (TSH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | FSH Monitoring Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 16084880Filicori 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.
- Background: PubMed 23931964Huber 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.
- Background: PubMed 22659248Jeppesen 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.
- Background: PubMed 24077980La 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.
- Background: PubMed 34973935Lawrenz 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.
- Background: PubMed 16434510Macklon 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.
- Individual participant dataSharing planned: No. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Stimulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonalyn Edades (+971526408688, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572930, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.