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Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

NCT04549116 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2026-01-26

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years. This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen embryo transfer (FET) in a modified natural cycle as a treatment for infertile women. Subjects will be randomized to receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support and these two groups will be compared.

Conditions

Interventions

DRUG

Progesterone-IBSA Injectable Solution

Progesterone-IBSA 25mg, twice daily (BID) SC Injection every 12 hours

DRUG

Progesterone Vaginal Gel with Applicator

Crinone 8%, 90 mg, QD intravaginally

DRUG

Placebo Vaginal gel with applicator

Vaginal gel Placebo, once daily (QD) intravaginally

DRUG

Placebo injectable solution

Placebo injectable solution, BID SC Injection every 12 hours

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2026-01-20
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04549116 on ClinicalTrials.gov