Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation.
Marco Filicori, Graciela Estela Cognigni, Elena Gamberini...
https://pubmed.ncbi.nlm.nih.gov/16084880Actively Recruiting
Age: 18Years - 39Years
FEMALE
Healthy Volunteers
ID06572930
Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders
Led by ART Fertility Clinics LLC · Updated on 2025-02-24
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict the number of eggs retrieved and progesterone levels during ovarian stimulation. The study considers factors such as age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH to identify a minimum FSH level that supports optimal ovarian response and allows personalized FSH dosing. Women undergoing ovarian stimulation will receive a fixed daily dose of 300 IU Gonal-F starting on cycle day 2 or 3, with injections at 8 pm. From stimulation day 5 until the trigger day, participants will also receive daily 250 mcg Cetrotide injections at 8 am. Blood samples will be collected on cycle day 2/3, and days 5, 8, 10 of stimulation, plus the trigger day, alongside urine samples. Final egg maturation will be triggered using recombinant human Choriogonadotropin and Decapeptyl when more than two follicles reach 17 mm. If participants have more than 30 follicles ≥12 mm or estradiol levels above 5000 pg/ml on trigger day, only Decapeptyl will be used. Egg retrieval occurs 36 hours after triggering. Participants will have follicular fluid from the largest follicle analyzed for FSH levels after egg collection. Researchers will perform quantitative measurements of serum FSH during stimulation over one year. The study includes regular ultrasound and blood tests to monitor follicle growth and hormone levels. This observational study involves women aged 18 to 39 years with defined ovarian and hormonal criteria, with safety and response closely assessed throughout.
CONDITIONS
Brief Title
Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation
Who Can Participate
Age: 18Years - 39Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female with regular menstrual cycles lasting 21 to 35 days
- Body mass index (BMI) between 19 and 30 kg/m2
- Serum AMH level between 1.5 and 3 ng/ml
- Total antral follicle count between 10 and 24
- Endogenous early follicular phase serum FSH level less than 10 IU/L
- Normal glomerular filtration rate (kidney function)
You will not qualify if you...
- Hypogonadotropic hypogonadism
- History of ovarian surgery
- Permanent ovarian cysts of any kind
- Older than 39 years
- Abnormal thyroid stimulating hormone (TSH) levels
- Renal disease
- Elevated prolactin levels
- Use of oral contraceptives within 3 months before stimulation start
- Use of estradiol pretreatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Approximately 10 to 12 days
Participants undergo ovarian stimulation with daily injections and have blood and urine samples taken to monitor serum FSH levels and follicle growth during the stimulation cycle.
5 visits (in-person) on cycle day 2/3, day 5, day 8, day 10, and trigger day
Oocyte Retrieval and Follicular Fluid Sampling
Duration - 1 day
Participants undergo oocyte pick up 36 hours after trigger, during which follicular fluid is collected for FSH level analysis.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
ART Fertility Clinics
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202
Actively Recruiting
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Research Team
J
Jonalyn Edades
B
Baris Ata, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Malin Huber, Nermin Hadziosmanovic, Lars Berglund...
https://pubmed.ncbi.nlm.nih.gov/23931964LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles.
Janni Vikkelsø Jeppesen, Stine Gry Kristensen, Maria Eilsø Nielsen...
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Antonio La Marca, Sesh Kamal Sunkara
https://pubmed.ncbi.nlm.nih.gov/24077980Reintroducing serum FSH measurement during ovarian stimulation for ART.
Barbara Lawrenz, Laura Melado, Shieryl Digma...
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Nick S Macklon, Richard L Stouffer, Linda C Giudice...
https://pubmed.ncbi.nlm.nih.gov/16434510