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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-39
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

hypogonadotropic hypogonadism

history of ovarian surgery

permanent ovarian cysts of any form

older than 39 years

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: FSH Monitoring Group1 intervention

Trial outcomes

Primary outcomes

1

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

serum FSH levels during ovarian stimulation

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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