NCT07450300

Brief Summary

This retrospective study included 1,831 single blastocyst frozen embryo transfer (FET) cycles performed between November 1, 2022 and August 31, 2025. Three endometrial preparation protocols were used according to ovulatory status, cycle duration, and characteristics of previous FET cycles: modified natural cycle with ovulation trigger (mNC-FET) (n = 770), stimulated cycle FET (SC-FET) (n = 468), and hormone replacement therapy FET (HRT-FET) (n = 593). In natural cycles, if the predefined criteria for ovulation trigger were not met, the cycle was converted to a stimulated cycle. The aim of this study was to determine whether body mass index affects embryo transfer feasibility, reproductive outcomes, and cycle characteristics across different FET protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 19, 2026

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • feasibility of embryo transfer

    Proportion of treatment cycles in which the planned frozen embryo transfer (FET) was performed as scheduled, regardless of the number of embryos transferred.

    scheduled day of embryo transfer (Day 0 of planned FET cycle)

Secondary Outcomes (4)

  • Clinical pregnancy

    6 weeks after embryo transfer

  • Miscarriage rate

    12 weeks of gestation

  • Cycle cancellation rate

    scheduled day of embryo transfer

  • Conversion from natural to stimulated cycles

    time of treatment protocol modification during the stimulation phase (prior to ovulation trigger)

Study Arms (3)

Modified natural cycle

Procedure: Modified natural cycle

Stimulated cycle

Procedure: Substitued cycle

Hormonal replacement therapy

Procedure: Hormonal replacement therapy

Interventions

In the modified natural cycle group, patients underwent ultrasound and hormonal monitoring to track spontaneous follicular development. When the leading follicle reached an appropriate size and endometrial thickness was adequate, ovulation was triggered using human chorionic gonadotropin (hCG) to schedule frozen embryo transfer.

Modified natural cycle

In the stimulated cycle group, mild ovarian stimulation was performed using oral agents and/or low-dose gonadotropins to promote follicular development. Follicular growth was monitored by ultrasound, and ovulation was either triggered with hCG or occurred spontaneously, allowing scheduling of frozen embryo transfer.

Stimulated cycle

In the hormone replacement therapy group, endometrial preparation was achieved through exogenous estrogen administration. Once adequate endometrial thickness was confirmed, progesterone supplementation was initiated to mimic the luteal phase and schedule frozen embryo transfer.

Hormonal replacement therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing assisted reproductive technology (ART) with frozen embryo transfer (FET) at a tertiary fertility center were retrospectively identified. The study population included adult patients who underwent endometrial preparation using one of the following protocols: modified natural cycle with ovulation trigger, stimulated cycle, or hormone replacement therapy (HRT). Participants were categorized according to body mass index (BMI) into obese and non-obese groups for comparative analysis of embryo transfer feasibility and reproductive outcomes.

Women aged ≥18 years at the time of frozen embryo transfer. Patients undergoing assisted reproductive technology (ART) with frozen embryo transfer (FET) using a natural, modified natural, stimulated, or hormone replacement therapy (HRT) protocol. Availability of body mass index (BMI) measurement prior to initiation of the treatment cycle.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Clinique Mathilde

Rouen, 76000, France

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 4, 2026

Study Start

November 1, 2022

Primary Completion

August 31, 2025

Study Completion

January 31, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations