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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2022 |
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Main ID: |
NCT03428165 |
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Date of registration:
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05/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate
TECNAT |
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Scientific title:
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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 |
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Date of first enrolment:
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March 7, 2018 |
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Target sample size:
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103 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03428165 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Stéphanie Huberlant |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nimes |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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in Vitro Fertilization
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Intervention(s)
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Other: HCG
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Primary Outcome(s)
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Pregnancy rate after transfer of frozen embryos at day 14 between groups
[Time Frame: Day 14]
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Secondary Outcome(s)
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Live birth
[Time Frame: At delivery, maximum week 42]
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Pregnancy term
[Time Frame: At delivery, maximum week 42]
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Birth weight
[Time Frame: At delivery, maximum week 42]
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Pregnancy rate at week 12
[Time Frame: Week 12]
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Number of visits for endometrial preparation until attaining LH peak
[Time Frame: Day 0]
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Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)
[Time Frame: Day 0]
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Miscarriage rate within first 12 weeks
[Time Frame: Week 12]
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Secondary ID(s)
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NIMAO/2017-02/SH-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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