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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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12 April 2021 |
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Main ID: |
NCT01058252 |
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Date of registration:
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27/01/2010 |
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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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Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF
MSP-INVO IVF |
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Scientific title:
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A Scientific & Clinical Review of Minimal Stimulation Protocol Using AROMEK (Letrozole) and Follitrope (Recombinant FSH)Combined With INVOCell(Intravaginal Culturing) - Effectiveness as Low Cost IVF |
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Date of first enrolment:
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May 2021 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01058252 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Dr Gul Rana, MBBS |
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Address:
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Telephone:
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+923353039246 |
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Email:
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gulrana8@gmail.com |
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Affiliation:
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Name:
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Dr Gul Rana, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ova IVF & Reproductive Health Clinics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Tubal factor without Hydrosalpinx
- Unexplained infertility with unsuccessful attempts in achieving pregnancy through
timed intercourse or IUI
- Boarder line male factor infertility
- Sperm DNA Fragmentation < 30%
- Normal Uterine Cavity
- Normal baseline ultrasound with adequate number of primary follicles present
- Normal FSH and E2 on Day 3
- Age of the female is < 35 years old
Exclusion Criteria:
- If previous IVF or INVO attempts resulted in failed fertilisation
- Male partner who has difficulty in producing semen sample
- Very low sperm count, very low percentage of sperm motility and morphology
- Sperm DNA Fragmentation > 30%
- Age of female patient > 37 years
- Borderline or elevated E2 or FSH on day 3 or failed CCCT or low blood inhibin levels
- Poor ovarian response
- Hydrosalpinx
- Anatomic difficulties in reaching ovaries for oocyte retrieval
- Cervical stenosis, making embryo transfer difficult
- Uterine abnormalities or deformities
- Obesity
Age minimum:
20 Years
Age maximum:
37 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Secondary Infertility
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Mild to Moderate Male Factor Infertility
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Primary Infertility
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Low Responders
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Intervention(s)
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Procedure: STEP-5: OPU, ET, Cancellation
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Procedure: STEP-3: LH Suppression & Monitoring
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Procedure: STEP-4: HCG Timing
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Combination Product: INVOCell, Letrozole 2.5 mg, recFSH 75 IU
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Procedure: INVOCell (Intravaginal Culturing)
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Primary Outcome(s)
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Number of Follicles >18 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate
[Time Frame: Quarterly]
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Secondary Outcome(s)
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Pregnancy Rate; Cost of Treatment
[Time Frame: Every 6 months]
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Secondary ID(s)
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GIVF-SRM 1001
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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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