NCT04549116

Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

A Multicenter, Randomized, Controlled, Double-blind, Double-dummy Study to Evaluate the Safety and Efficacy of Subcutaneous Progesterone Compared to Vaginal Progesterone for Luteal Phase Supplementation in Modified Natural Frozen Euploid Blastocyst Transfer.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Female
• Age: 35 Years – 42 Years
• Healthy volunteers: Not accepted

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

• Infertility

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-12
• Primary completion: 2026-01-20
• Completion: 2026-06-30
• First posted: 2020-09-16
• Last updated: 2026-01-26

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study