NCT06859944

Brief Summary

Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or "Natural proliferative phase - frozen embryo transfer" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2024Jun 2026

Study Start

First participant enrolled

August 5, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

February 27, 2025

Last Update Submit

March 5, 2025

Conditions

Comparison of Pregnancy Rate (HCG+ Level) Obtained After a Replacement Embryonic in Spontaneous Cycle and Following Protocol "NPP". Comparison

Outcome Measures

Primary Outcomes (1)

  • Comparison of the pregnancy rate (Human chorionic gonadotropin hormone) (HCG+ level) obtained after spontaneous embryo replacement and following the "NPP" protocol.

    Thrugh study completion (9 months)

Study Arms (2)

single transfer of frozen blastocyst in natural cycle

Other: Embryo transfer

Natural Cycle Programmed by Progesterone

Other: Embryo transfer

Interventions

Embryo transferOTHER

Frozen embryo transfer

Natural Cycle Programmed by Progesterone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with regular cycles, candidates for replacement of embryos frozen in spontaneous cycle
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with regular cycles, candidates for replacement of embryos frozen in spontaneous cycle

You may qualify if:

  • Single transfer Blastocyste

You may not qualify if:

  • PGT (Preimplantation genetic diagnosis)
  • Testicular Sperm
  • Donor oocytes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Interventions

Embryo Transfer

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Central Study Contacts

Anne Delbaere

CONTACT

+32 2 555 45 70anne.delbaere@hubruxelles.be

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

August 5, 2024

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)