Clinical trial NCT01058252: Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Infertility
Secondary Infertility
Low Responders
Mild to Moderate Male Factor Infertility
Lead sponsor: Galaxy Pharma (Pvt) Limited
Sponsor class: INDUSTRY
Collaborators: name: Ova IVF & Reproductive Health Clinics, Karachi
First posted: 2010-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF Network Centers across the country, selecting patients meeting inclusion and exclusion criteria.

Brief summary: The purpose of this study to evaluate a low cost minimal stimulation protocol combined with Intravaginal Culturing, to make IVF affordable and available across the large infertile/subfertile population

Detailed description: In routine ART procedures for IVF, ovarian stimulation is performed using down regulation with GNRH Agonist combined with high daily FSH doses followed with ovulation induction with HCG 10000 IU, ovum pick-up 34-36 hours after HCG injection and embryo transfer on day 2, 3 or 5.

In routine ART procedure for IVF, embryology is done in very high tech lab, contamination free environment, which also exclude VOC, high quality CO2 Incubators, laminar flow with heated table top, high magnification stereo microscope along with equipments for maintaining quality control, with a highly trained embryologist. The primary reason is we need to create a womb like environment in the embryology lab as eggs, and mainly fertilised embryos are going to spend minimum 2 or 3 and in case blastocyst 5 days in this lab.

In recent years, various studies have been published identifying various minimal stimulation protocols for IVF, and also another variation of IVF where rather than using CO2 Incubator for culturing, vaginal cavity of the female partner is used for incubation using a specially designed capsule which have walls permeable to vaginal pCO2 and O2. Oocytes are retrieved by the physician and handed over to basic embryologist to identify and grade oocytes and washed sperms are placed in a embryo toxic tested, sterile, individual single use capsule (INVOCell) and placed in vaginal cavity using diaphragm, patient goes back to home with some instructions for care, on day 2 patient comes back to the IVF Clinic and physician gets the capsule out and hands over to the basic embryologist trained on INVOCell to identify embryos and grade them, further loading of embryos on ET Catheter.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Follicles >18 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate
timeFrame: Quarterly
Secondary outcomes:
measure: Pregnancy Rate; Cost of Treatment
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Wallington Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Ova IVF & Reproductive Health Clinics
state: Sindh
Study officials:
affiliation: Ova IVF & Reproductive Health Clinics
name: Dr Gul Rana, MBBS
role: STUDY_DIRECTOR
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