Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET) (NPP)

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.

Study Overview

• Status: Recruiting
• Conditions: Comparison of Pregnancy Rate (HCG+ Level) Obtained After a Replacement Embryonic in Spontaneous Cycle and Following Protocol "NPP". Comparison
• Intervention / Treatment: Other: Embryo transfer; Other: Embryo transfer

Detailed Description

The protocol Natural proliferative phase/Natural Programmed by Progesterone, Patients with regular cycles, candidates for replacement of embryos frozen in a spontaneous cycle. The monitoring of the cycle is carried out by taking blood and follicular ultrasound between the 10th and 13th day of the cycle. Support luteal phase by intravaginal progesterone (utrogestan 200 mg) 1 tablet, 2 times per day, is initiated once the following criteria are met:

• Thickness of the endometrium > 7 mm on ultrasound
• Ovarian follicle > 14 mm
• Estradiol( E2) > 120 pg/mL Embryo transfer is scheduled on the 6th day of progesterone exposure exogenous. A progesterone dosage on the day of transfer will be systematically realized

• Study Type: Observational
• Enrollment (Estimated): 272

Contacts and Locations

• Study Contact: Name: Anne Delbaere; Phone Number: +32 2 555 45 70; Email: anne.delbaere@hubruxelles.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Hôpital Erasme
    • Contact: Anne Delbaere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Single transfer Blastocyste

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single transfer of frozen blastocyst in natural cycle	Other: Embryo transfer; Frozen embryo transfer; Other: Embryo transfer; Frozen Embryo transfer
Natural Cycle Programmed by Progesterone	Other: Embryo transfer; Frozen embryo transfer; Other: Embryo transfer; Frozen Embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SRB2024108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No