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NCT04549116 · ClinicalTrials.gov registry record · Phase 3
Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.
A Phase 3 study of Infertility, sponsored by IBSA Institut Biochimique.
- Active
- Registry status
- Phase 3
- Development phase
- 680
- Enrollment target
- 20
- Study locations
NCT04549116: Active Phase 3 study of Infertility, sponsored by IBSA Institut Biochimique.
NCT04549116 is a Phase 3 study of Infertility that is active but no longer recruiting, run by IBSA Institut Biochimique. The registered enrollment target is 680 participants, below the 7,580-participant average among 74 other Infertility trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04549116, a Phase 3 study of Infertility, is active but no longer recruiting, sponsored by IBSA Institut Biochimique.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 680 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
defined by the presence of an intrauterine fetal heart beat
Conditions Studied
Interventions
- DRUG Progesterone-IBSA Injectable Solution
- DRUG Progesterone Vaginal Gel with Applicator
- DRUG Placebo Vaginal gel with applicator
- DRUG Placebo injectable solution
Study Locations (20)
California
- HRC Fertility - Encino
- Kindbody - Los Angeles
- San Diego Fertility - San Diego
- Spring Fertility - San Francisco
Florida
- Women's Medical Research Group, LLC - Clearwater
- IVF Florida Reproductive Associates - Margate
- The IVF Center - Winter Park
North Carolina
- Reproductive Endocrinology Associates of Charlotte - Charlotte
- Carolina Conceptions - Raleigh
Pennsylvania
- Main Line Fertility - Bryn Mawr
- Shady Grove Fertility - Chesterbrook
Texas
- Care Fertility - Bedford
- Aspire Houston Fertility Institute - Houston
Arizona
- The Fertility Treatment Center, LLC - Tempe
Connecticut
- Illume Fertility - Norwalk
Delaware
- Reproductive Associates of Delaware - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04549116 still lists
NCT04549116 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, below the 7,580-participant average among 74 other Infertility trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Infertility appearing as the primary indexed condition, and to 4 interventions - of which Progesterone-IBSA Injectable Solution is the first listed.
NCT04549116 names 20 study sites across 12 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04549116 about?
NCT04549116 is a clinical study titled "Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.". 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 e...
What is the current status of trial NCT04549116?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2022-10-12. Estimated completion is 2026-06-30.
What conditions does trial NCT04549116 study?
This clinical trial studies the following conditions: Infertility.
What interventions are being tested in trial NCT04549116?
The interventions under investigation include: Progesterone-IBSA Injectable Solution (DRUG), Progesterone Vaginal Gel with Applicator (DRUG), Placebo Vaginal gel with applicator (DRUG), Placebo injectable solution (DRUG).
Who is sponsoring clinical trial NCT04549116?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04549116 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04549116's enrollment target sits among peer trials
680 20th of 74 higher than 55 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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