NCT07738068 Progesterone Infertility, Female Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07738068 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 5 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07738068 is a hot trial to watch
Infertility, Female is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07738068 is notable because it evaluates Progesterone in a Phase 3 design sponsored by University Medical Center of Utrecht. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07738068 |
| Official title | Progesterone Luteal Support in Unexplained Infertility Management (PLUIM) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Progesterone |
| Sponsor | University Medical Center of Utrecht |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Pregnancy occurring within 6 months after randomisation, leading to a live birth. |
| Endpoint time frame | within 6 months after randomisation |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The purpose of this study is to evaluate whether progesterone in women with unexplained infertility can increases live birth rate. The main research question is: Does luteal phase support with progesterone increase the live birth rate among couples with unexplained infertility? The study compares progesterone with placebo to determine the effectiveness of progesterone in unexplained infertility. Study participants will: * Perform home ovulation tests and maintain a digital diary to record menstrual cycles and study medication use.10 * Take progesterone or placebo twice daily during the luteal phase of each menstrual cycle for up to six months.11 * Continue usual medical care. No additional hospital visits or invasive procedures are required as part of the study.
Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Pregnancy occurring within 6 months after randomisation, leading to a live birth. (within 6 months after randomisation)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Progesterone is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: University Medical Center of Utrecht is resolved to a normalized organization record in Netherlands. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07738068 provides a focused lens on Infertility, Female development. Its value will be determined by whether Progesterone can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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