Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)

Sponsor
Clinique Ovo (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06053827
Collaborator
(none)
500
1
12.4
40.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Frozen embryo transfer

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Embryo Transfer in Natural vs Substituted Cycle and the Scheduling Pattern of IVF
Actual Study Start Date :
Sep 19, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the clinical pregnancy rate of embryo transfer in natural vs substituted cycles [6 to 8 weeks after Frozen Embryo Transfer]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 40 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Ovo Montréal Quebec Canada H4P 2S4

Sponsors and Collaborators

  • Clinique Ovo

Investigators

  • Principal Investigator: Camille Sylvestre, MD, clinique ovo R&D department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique Ovo
ClinicalTrials.gov Identifier:
NCT06053827
Other Study ID Numbers:
  • 3356
First Posted:
Sep 26, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 28, 2023