MedTrace Logo

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

NCT07346235 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

DRUG

Follicle-stimulating hormone (FSH)

Daily subcutaneous injection of 150 IU FSH

DRUG

Follicle-stimulating hormone (FSH)

Daily subcutaneous injection of 225 IU FSH

Sponsors & Collaborators

  • American Hospital 2 Kosovo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-01-01
Completion
2029-01-15

Countries

  • Kosovo

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346235 on ClinicalTrials.gov