Infertility, FemalePhase 3OPTIMAL-DOSENCT07346235
150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
A Phase 3 study testing Follicle-stimulating hormone (FSH) in people with Infertility, Female, run by American Hospital 2 Kosovo.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Follicle-stimulating hormone (FSH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 15 Jan 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index (BMI) 18-30 kg/m².
- Predicted normal ovarian reserve:
- Anti-Müllerian Hormone (AMH) 1.2-3.5 ng/mL (measured within 12 months), AND Antral Follicle Count (AFC) 8-20 (both ovaries combined, measured on day 2-5 of the cycle).
- First or second IVF/ICSI cycle.
- Planned GnRH antagonist protocol.
- Both ovaries present and accessible.
- Written informed consent provided voluntarily.
Who cannot join
- Predicted poor or high ovarian response (AMH <1.2 or >3.5 ng/mL; AFC <8 or >20).
- Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria.
- Severe endometriosis (Stage III-IV per ASRM).
- Severe uterine abnormalities affecting implantation.
- Previous complete fertilization failure (fertilization rate <30%).
- Severe male factor (sperm count <5 million/mL, or requirement for donor sperm/TESE).
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- Uncontrolled endocrine disorders (uncontrolled hypothyroidism, hyperprolactinemia, diabetes).
- Contraindications to pregnancy or gonadotropins.
- Participation in another clinical trial within 30 days.
- Inability to provide informed consent.
About this study
Official title: OPTIMAL-DOSE: A Randomized, Open-Label, Non-Inferiority Trial Comparing Fixed Daily Doses of 150 IU Versus 225 IU of Follicle-Stimulating Hormone in Predicted Normal Responders Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection
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.
Read the detailed description
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.
- Conditions
- Infertility, Female
- Being tested
- Follicle-stimulating hormone (FSH)
- Keywords
- IVF, ICSI, FSH, Gonadotropin, Ovarian Stimulation, Normal Responder, Live Birth Rate, OHSS
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle-stimulating hormone (FSH)Drug
Daily subcutaneous injection of 150 IU FSH
Follicle-stimulating hormone (FSH)Drug
Daily subcutaneous injection of 225 IU FSH
| Study group | Role | What they receive |
|---|---|---|
| 150 IU FSH Group | Experimental | 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. Receives: Drug: Follicle-stimulating hormone (FSH) |
| 225 IU FSH Group | Active comparator | 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. Receives: Drug: Follicle-stimulating hormone (FSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after randomization
Secondary outcomes (6)
Number of Oocytes Retrieved
Total number of oocytes retrieved at oocyte pick-up.
Measured: Up to 2 weeks
Incidence of Moderate/Severe OHSS
Proportion of participants developing moderate or severe OHSS according to Golan classification.
Measured: Up to 4 weeks after oocyte retrieval
Total FSH Consumption
Total amount of FSH (in IU) used during the stimulation cycle.
Measured: Up to 2 weeks
Clinical Pregnancy Rate
Presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation.
Measured: 7 weeks of gestation
Live Birth Rate per Transfer
Delivery of a live-born infant per embryo transfer procedure.
Measured: Up to 12 months after randomization
Cycle Cancellation Rate
Proportion of cycles cancelled before oocyte retrieval.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Why it stopped: Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Hospital 2 Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goksu Goc, American Hospital 2 Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346235
- Sponsor's protocol ID
- OPTIMAL-DOSE-2026-001
- Acronym
- OPTIMAL-DOSE
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Tilborg TC, Torrance HL, Oudshoorn SC, Eijkemans MJC, Koks CAM, Verhoeve HR, Nap AW, Scheffer GJ, Manger AP, Schoot BC, Sluijmer AV, Verhoeff A, Groen H, Laven JSE, Mol BWJ, Broekmans FJM; OPTIMIST study group. Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 1: The predicted poor responder. Hum Reprod. 2017 Dec 1;32(12):2496-2505. doi: 10.1093/humrep/dex318.
PubMed 29121326
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMAL-DOSE: A Randomized, Open-Label, Non-Inferiority Trial Comparing Fixed Daily Doses of 150 IU Versus 225 IU of Follicle-Stimulating Hormone in Predicted Normal Responders Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT07346235
- Acronym / sponsor ID
- OPTIMAL-DOSE / OPTIMAL-DOSE-2026-001
- Conditions
- Infertility, Female
- Keywords
- IVF, ICSI, FSH, Gonadotropin, Ovarian Stimulation, Normal Responder, Live Birth Rate, OHSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Hospital 2 KosovoUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 16 Jan 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150 IU FSH Group | Experimental | Drug: Follicle-stimulating hormone (FSH)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. |
| 225 IU FSH Group | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body Mass Index (BMI) 18-30 kg/m².
- Predicted normal ovarian reserve:
- Anti-Müllerian Hormone (AMH) 1.2-3.5 ng/mL (measured within 12 months), AND Antral Follicle Count (AFC) 8-20 (both ovaries combined, measured on day 2-5 of the cycle).
- First or second IVF/ICSI cycle.
- Planned GnRH antagonist protocol.
Key exclusion criteria (10 listed)
- Predicted poor or high ovarian response (AMH <1.2 or >3.5 ng/mL; AFC <8 or >20).
- Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria.
- Severe endometriosis (Stage III-IV per ASRM).
- Severe uterine abnormalities affecting implantation.
- Previous complete fertilization failure (fertilization rate <30%).
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 |
|---|---|---|
| Follicle-stimulating hormone (FSH)Daily subcutaneous injection of 150 IU FSH | Drug | 150 IU FSH Group |
| Follicle-stimulating hormone (FSH)Daily subcutaneous injection of 225 IU FSH | Drug | 225 IU FSH Group |
Primary outcome
Cumulative Live Birth Rate per Initiated Cycle
Time frame: Up to 12 months after randomization
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.
6 secondary outcomes
Number of Oocytes Retrieved
Time frame: Up to 2 weeks
Incidence of Moderate/Severe OHSS
Time frame: Up to 4 weeks after oocyte retrieval
Total FSH Consumption
Time frame: Up to 2 weeks
Clinical Pregnancy Rate
Time frame: 7 weeks of gestation
Live Birth Rate per Transfer
Time frame: Up to 12 months after randomization
Cycle Cancellation Rate
Time frame: Up to 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 29121326van Tilborg TC, Torrance HL, Oudshoorn SC, Eijkemans MJC, Koks CAM, Verhoeve HR, Nap AW, Scheffer GJ, Manger AP, Schoot BC, Sluijmer AV, Verhoeff A, Groen H, Laven JSE, Mol BWJ, Broekmans FJM; OPTIMIST study group. Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 1: The predicted poor responder. Hum Reprod. 2017 Dec 1;32(12):2496-2505. doi: 10.1093/humrep/dex318.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Follicle-stimulating hormone (FSH) in people with Infertility, Female, run by American Hospital 2 Kosovo.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Live Birth Rate per Initiated Cycle (time frame: Up to 12 months after randomization). 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 NCT07346235, which also lists 1 linked publication.
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 29 Oct 2026.