150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial

NCT07346235 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: OPTIMAL-DOSE-2026-001
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Infertility, Female

Keywords

IVF; ICSI; FSH; Gonadotropin; Ovarian Stimulation; Normal Responder; Live Birth Rate; OHSS

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months after randomization

Secondary Outcomes (6)

• Number of Oocytes Retrieved

  Up to 2 weeks

• Incidence of Moderate/Severe OHSS

  Up to 4 weeks after oocyte retrieval

• Total FSH Consumption

  Up to 2 weeks

• Clinical Pregnancy Rate

  7 weeks of gestation

• Live Birth Rate per Transfer

  Up to 12 months after randomization

Study Arms (2)

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.

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.

Drug: Follicle-stimulating hormone (FSH)

Interventions

Follicle-stimulating hormone (FSH) DRUG

Daily subcutaneous injection of 150 IU FSH

150 IU FSH Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• American Hospital 2 Kosovo: lead

Study Sites (1)

American Hospital Kosova

Pristina, 1000, Kosovo

Location

Related Publications (1)

• 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.

  PMID: 29121326 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Follicle Stimulating Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Goksu Goc, MD

CONTACT

+38349878550; goksu.goc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)