Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate (TECNAT)
Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- CHU Arnaud de Villeneuve
-
Nîmes, France, 30029
- CHU Nîmes
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is aged between 18 and 40
- Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)
Exclusion Criteria:
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient using donated oocytes
- Necessity of pre-implantation diagnosis
- Patients with stage 3 or 4 endometriosis or adenomyosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: human chorionic gonadotropin (HCG)
Ovulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml
|
250 μg/0.5ml
choriogonadotropine alpha, Ovitrelle, Merck Serono
|
|
No Intervention: spontaneous
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy rate after transfer of frozen embryos at day 14 between groups
Time Frame: Day 14
|
Yes/no; Blood ßHCG > 100UI/L
|
Day 14
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy rate at week 12
Time Frame: Week 12
|
Yes/no; ultrasound
|
Week 12
|
|
Miscarriage rate within first 12 weeks
Time Frame: Week 12
|
Yes/no; ultrasound
|
Week 12
|
|
Live birth
Time Frame: At delivery, maximum week 42
|
Yes/no
|
At delivery, maximum week 42
|
|
Pregnancy term
Time Frame: At delivery, maximum week 42
|
Weeks
|
At delivery, maximum week 42
|
|
Birth weight
Time Frame: At delivery, maximum week 42
|
Kg
|
At delivery, maximum week 42
|
|
Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)
Time Frame: Day 0
|
Yes/no
|
Day 0
|
|
Number of visits for endometrial preparation until attaining LH peak
Time Frame: Day 0
|
Number of visits
|
Day 0
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Stéphanie Huberlant, CHU Nîmes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- NIMAO/2017-02/SH-01
- 2017-A02759-44 (Other Identifier: ANSM)
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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