A Phase 3 interventional study of Follicle-stimulating hormone (FSH) and Follicle-stimulating hormone (FSH) in Infertility, Female, sponsored by American Hospital 2 Kosovo. Withdrawn. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by American Hospital 2 Kosovo · Phase 3, Interventional, and Treatment
Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
This is a single-center, randomized, open-label, non-inferiority trial comparing two fixed daily doses of follicle-stimulating hormone (FSH): 150 IU versus 225 IU in women with predicted normal ovarian response undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with a gonadotropin releasing hormone (GnRH) antagonist protocol. The primary objective is to determine whether the 150 IU dose is noninferior to the 225 IU dose regarding the cumulative live birth rate per initiated cycle. Secondary objectives include comparing oocyte yield, incidence of OHSS, treatment costs, and patient-reported outcomes.
Background: Controlled ovarian stimulation (COS) with exogenous FSH is a cornerstone of IVF treatment. The optimal starting dose of FSH for women with normal ovarian reserve remains controversial, with doses ranging from 150 IU to 300 IU used in clinical practice.
Both 150 IU and 225 IU are widely used, but no randomized controlled trial has directly compared these two specific doses in predicted normal responders.
Objective: To determine if a fixed daily dose of 150 IU FSH is non-inferior to 225 IU FSH with respect to cumulative live birth rate per initiated cycle.
Methods: A total of 440 women (220 per group) will be randomized 1:1 to receive either 150 IU or 225 IU of FSH daily, starting on day 2-3 of the menstrual cycle. All participants will follow a standard GnRH antagonist protocol. The primary outcome is cumulative live birth rate, defined as the delivery of at least one live-born infant at ≥24 weeks of gestation from the first fresh or any subsequent frozen embryo transfer from a single stimulation cycle. The non-inferiority margin is set at -10% (absolute difference).
Significance: If 150 IU is proven non-inferior, this would support the use of a lower dose, potentially reducing treatment costs and the risk of ovarian hyperstimulation syndrome (OHSS) without compromising efficacy.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
Browse Infertility, Female studies →This is the only study on the registry with American Hospital 2 Kosovo as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a fixed daily dose of 150 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.
Drug: Follicle-stimulating hormone (FSH)
Participants receive a fixed daily dose of 225 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.
Drug: Follicle-stimulating hormone (FSH)
Daily subcutaneous injection of 150 IU FSH
Daily subcutaneous injection of 225 IU FSH
Cumulative Live Birth Rate per Initiated Cycle
The delivery of at least one live-born infant at ≥24 weeks of gestation resulting from the first fresh embryo transfer or any subsequent frozen embryo transfer from a single stimulation cycle.
Time frame: Up to 12 months after randomization
Number of Oocytes Retrieved
Total number of oocytes retrieved at oocyte pick-up.
Time frame: Up to 2 weeks
Incidence of Moderate/Severe OHSS
Proportion of participants developing moderate or severe OHSS according to Golan classification.
Time frame: Up to 4 weeks after oocyte retrieval
Total FSH Consumption
Total amount of FSH (in IU) used during the stimulation cycle.
Time frame: Up to 2 weeks
Clinical Pregnancy Rate
Presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation.
Time frame: 7 weeks of gestation
Live Birth Rate per Transfer
Delivery of a live-born infant per embryo transfer procedure.
Time frame: Up to 12 months after randomization
Cycle Cancellation Rate
Proportion of cycles cancelled before oocyte retrieval.
Time frame: Up to 2 weeks
No study locations are listed for this record.
Plan to share: No
Start is estimated for Mar 2026; primary completion for Jan 2028, 22 months later.
How these figures are worked out, and which studies are left out of them.
Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Follicle Stimulating Hormone