Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.
Public ClinicalTrials.gov record NCT04549116. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04549116
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 688 participants
Conditions and interventions
Conditions
Interventions
- Progesterone-IBSA Injectable Solution Drug
- Progesterone Vaginal Gel with Applicator Drug
- Placebo Vaginal gel with applicator Drug
- Placebo injectable solution Drug
Drug
Eligibility (public fields only)
- Age range
- 35 Years to 42 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 12, 2022 (Actual)
- Primary completion
- Jan 20, 2026 (Actual)
- Completion
- Aug 25, 2026 (Actual)
- Last update posted
- Aug 27, 2026
2022 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Fertility Treatment Center, LLC | Tempe | Arizona | 85284 | — |
| HRC Fertility | Encino | California | 91436 | — |
| Kindbody | Los Angeles | California | 90067 | — |
| San Diego Fertility | San Diego | California | 92130 | — |
| Spring Fertility | San Francisco | California | 94109 | — |
| Illume Fertility | Norwalk | Connecticut | 06851 | — |
| Reproductive Associates of Delaware | Newark | Delaware | 19713 | — |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | — |
| IVF Florida Reproductive Associates | Margate | Florida | 33063 | — |
| The IVF Center | Winter Park | Florida | 32792 | — |
| InVia Fertility Specialists, PLLP | Hoffman Estates | Illinois | 60169 | — |
| Johns Hopkins Fertility Center | Lutherville | Maryland | 21093 | — |
| Shady Grove Fertility | Rockville | Maryland | 20850 | — |
| University Reproductive Associates, PC | Hasbrouck Heights | New Jersey | 07604 | — |
| Reproductive Endocrinology Associates of Charlotte | Charlotte | North Carolina | 28207 | — |
| Carolina Conceptions | Raleigh | North Carolina | 27607 | — |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | — |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45209 | — |
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010 | — |
| Shady Grove Fertility | Chesterbrook | Pennsylvania | 19087 | — |
| Care Fertility | Bedford | Texas | 76022 | — |
| Aspire Houston Fertility Institute | Houston | Texas | 77063 | — |
| Center of Reproductive Medicine, LLC., Shady Grove Fertility | Webster | Texas | 77598 | — |
| Utah Fertility Center, PC | Pleasant Grove | Utah | 84062 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04549116, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04549116 live on ClinicalTrials.gov.