NCT06053827

Brief Summary

In frozen embryo transfer substituted cycles, patients are treated with progesterone and estrogen in an attempt to mimic the natural cycle and a transfer is planned whenever the endometrium is ready. In contrast, in frozen embryo transfer natural cycle patients are not taking any hormones, only triggered with hCG (human chorionic gonadotropin) when a dominant follicle is ready or they wait for the disappearance of the dominant follicle to plan the transfer date. Some doctors and centres shift towards using the substituted protocol in an attempt to make scheduling easier with less frequent ultrasounds. This study will aim to compare clinical and biochemical pregnancy rates in patients who underwent frozen embryo transfers in natural cycles vs substituted cycles at the centre.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

September 19, 2023

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the clinical pregnancy rate of embryo transfer in natural vs substituted cycles

    clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound

    6 to 8 weeks after Frozen Embryo Transfer

Study Arms (2)

Frozen embryo transfer substituted cycle

In a substituted cycle, estrogen and progesterone are given and a transfer is planned when the endometrium is ready

Other: Frozen embryo transfer

Frozen embryo transfer natural cycle

In a natural cycle no hormones are given and a transfer is planned when there is a dominant follicle apparent at the ultrasound

Other: Frozen embryo transfer

Interventions

A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy

Frozen embryo transfer natural cycleFrozen embryo transfer substituted cycle

Eligibility Criteria

AgeUp to 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen able to have an embryo transfered in their uterus
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Data spreadsheet from Jan 2022 to March 2023 of patients undergoing natural or substituted frozen embryo transfer

You may qualify if:

  • Age \< 40 years old
  • Women having undergone either a frozen embryo transfer in natural cycle or substituted cycle
  • IVF and FET cycles done at Clinique OVO

You may not qualify if:

  • egg or embryo recipient
  • History of recurrent miscarriages, defined as ≥ 3 consecutive losses
  • Patients that needed Viagra, Plasma-Rich Platelet (PRP) or other modalities to improve their endometrial thickness
  • Uterine abnormalities
  • Abnormal hormonal profiles
  • FET Stimulated cycles
  • History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Study Officials

  • Camille Sylvestre, MD

    clinique ovo R&D department

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

September 19, 2023

Primary Completion

November 30, 2023

Study Completion

July 18, 2024

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations