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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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8 August 2016 |
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Main ID: |
NCT02429999 |
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Date of registration:
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25/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Letrozole in Assisted Reproductive Technology
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Scientific title:
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The Role of Aromatase Inhibitor (Letrozole) in Minimal Ovarian Stimulation Protocols in Assisted Reproductive Technology. A Randomized Controlled Trial |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02429999 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Amr Shehata Abd El badie |
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Address:
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Telephone:
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0882414621 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Unexplained infertility.
- Tubal factor. Included treated hydrosalpinx and pyosalpinx
- BMI 18-29.
- Antral follicle count (AFC) more than 5 follicles in one ovary.
- Normal male semen analysis.Mild male factor: concentrations 10 million - 20 million
sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.
Exclusion Criteria:
- Patients with Endometriosis.
- Azoospermic male.
- BMI more than 29.
Age minimum:
20 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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to Evaluate Letrozole as a Modality for Minimal Ovarian Stimulation in ICSI Cycles .
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Intervention(s)
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Drug: Standard protocol for induction of ovulation
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Drug: Letrezole plus FSH
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Primary Outcome(s)
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endometrial thickness/mm
[Time Frame: 2 years]
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number of oocytes retrieved
[Time Frame: 2 years]
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number transferable embryos
[Time Frame: 2 years]
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the levels of terminal E2 pg/mL
[Time Frame: 2 years]
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The number of mature follicles developed
[Time Frame: 2 years]
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total dose of FSH administered
[Time Frame: 2 years]
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Secondary Outcome(s)
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Number of patient who get pregnant
[Time Frame: 2 years]
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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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