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)

Last updated: March 5, 2025
Sponsor: Erasme University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Embryo transfer

Clinical Study ID

NCT06859944
SRB2024108
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Single transfer Blastocyste

Exclusion

Exclusion Criteria:

  • PGT (Preimplantation genetic diagnosis)

  • Testicular Sperm

  • Donor oocytes

Study Design

Total Participants: 272
Treatment Group(s): 1
Primary Treatment: Embryo transfer
Phase:
Study Start date:
August 05, 2024
Estimated Completion Date:
June 30, 2026

Study 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

Connect with a study center

  • Hopital Erasme

    Brussels, 1070
    Belgium

    Active - Recruiting

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