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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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20 September 2021 |
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Main ID: |
NCT04897269 |
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Date of registration:
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18/05/2021 |
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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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Progesterone Supplementation on Women Having Low Progesterone Levels on Transfer Day
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Scientific title:
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Effectiveness of Progesterone Supplementation for Women Having Low Progesterone Levels on the Day of Frozen Embryo Transfer |
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Date of first enrolment:
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May 20, 2021 |
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Target sample size:
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824 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04897269 |
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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: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Chau TM Le, PhD |
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Address:
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Telephone:
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0084908429006 |
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Email:
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dr.lethiminhchau@gmail.com |
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Affiliation:
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Name:
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Chau TM Le, PhD |
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Address:
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Telephone:
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+84908429006 |
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Email:
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dr.lethiminhchau@gmail.com |
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Affiliation:
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Name:
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Chau TM Le |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Infertility, Tu Du Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage
embryo transfer, from 18-45 years of age
- Normal BMI
- HRT for Endometrial preparation in FET cycles
Exclusion Criteria:
- Oocyte donor cycles
- Surrogacy
- IVM
- PGT
- Abnormal Uterine (firbroids 0 -> 3 according to FIGO classification, polyp,
adenomyosis, congenital malformation)
- Uterus fibroids type 4,5 (Figo classification) > 4cm
- History of recurrent implantation failure
- Endometrial thickness <7mm on the day of ET
- Cesarean scar defect (isthmocele)
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Assisted Reproductive Technology
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Intervention(s)
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Procedure: Progesterone supplementation
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Primary Outcome(s)
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Ongoing pregnancy rate
[Time Frame: week 11 - 14 of pregnancy]
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Secondary Outcome(s)
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clinical pregnancy
[Time Frame: 3 weeks after embryo transfer]
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implantation rate
[Time Frame: 3 weeks after embryo transfer]
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Pregnancy rate
[Time Frame: 2 weeks after embryo transfer]
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Secondary ID(s)
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656/BVTD-HDDD
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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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