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)

NCT ID: NCT06859944

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-05

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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single transfer of frozen blastocyst in natural cycle

Embryo transfer

Intervention Type OTHER

Frozen Embryo transfer

Natural Cycle Programmed by Progesterone

Embryo transfer

Intervention Type OTHER

Frozen embryo transfer

Interventions

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Embryo transfer

Frozen embryo transfer

Intervention Type OTHER

Embryo transfer

Frozen Embryo transfer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Single transfer Blastocyste

Exclusion Criteria

* PGT (Preimplantation genetic diagnosis)
* Testicular Sperm
* Donor oocytes
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Delbaere

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopital Erasme

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Anne Delbaere

Role: CONTACT

+32 2 555 45 70

Facility Contacts

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Anne Delbaere

Role: primary

Other Identifiers

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SRB2024108

Identifier Type: -

Identifier Source: org_study_id

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