- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053827
Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)
Embryo Transfer in Natural vs Substituted Cycle and the Scheduling Pattern of IVF
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4P 2S4
- Clinique ovo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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
|
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
|
A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the clinical pregnancy rate of embryo transfer in natural vs substituted cycles
Time Frame: 6 to 8 weeks after Frozen Embryo Transfer
|
clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound
|
6 to 8 weeks after Frozen Embryo Transfer
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Camille Sylvestre, MD, clinique ovo R&D department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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