Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

NCT04549116 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 680 participants
Start Date 2022-10-12
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

IBSA Institut Biochimique

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04549116

The ClinicalTrials.gov registry entry for NCT04549116 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IBSA Institut Biochimique, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04549116 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04549116?

This trial is sponsored by IBSA Institut Biochimique, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial