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
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.
Study Type
OBSERVATIONAL
Enrollment
30
OVARIAN STIMULATION: In previous cycles, cycle length and ovulatory status must be assessed and documented. STEP 1: ANOVULATION by ORAL CONTRACEPTION * Place patients on monophasic low dose of oral contraceptive pills (OCP) such as Marvelon (Organon, 0.03 mg) continuously for 21 days, 22 days but no more. * Before stopping the oral contraceptive pills, perform an ultrasound to check for the absence of cysts (no cyst \> 10 mm). * Give estradiol (2mg, 3 times a day) for 3 days from D21 or D22 and wait for bleeding. STEP 2: STIMULATION and MONITORING Day one of the cycle equals the first day of bleeding (not spotting). * On Day 3 (D3), start letrozol 2.5mg (AROMEK) for 5 days (D7). LetrozolE can be pushed for 2 more days. * Start hMG or FSH (75 IU a day) on Day 3 like LetrozolE and continue for 5 to 7 days without increasing the dose. The dose of hMG OR FSH can be increased to 150 IU a day if low responder.
Baseline Day-2 Ultrasound to estimate antral follicles; Follow-up TVS scans on Day- 5,6,7,8 and 9 of the stimulated cycle. Ideally the lead follicle should be 18 mm on or around day 10 of the cycle. • When the leading follicle reaches 14 to15 mm (D8 or D9), give Indomethacine (50 mg, 3 times a day) until the evening preceding the egg retrieval. The Indomethacine will prevent a premature ovulation. The endometrium should be minimum 8 mm on the day of HCG (IVF-C 5000 IU x 2) No need of LH testing, or E2 testsing during the stimulated cycle.
Lady Wallington Hospital
Lahore, Punjab Province, Pakistan
RECRUITINGOva IVF & Reproductive Health Clinics
Karachi, Sindh, Pakistan
RECRUITINGNumber of Follicles >18 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate
Time frame: Quarterly
Pregnancy Rate; Cost of Treatment
Time frame: Every 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IVF-C (HCG 10000 IU) shall be injected to trigger the ovulation, when any of the following occur: * E2 level is over 150 pg/ml/per mature follicle (\> 15 mm) * Domminent follicle is greater than 18 mm in mean diameter * LH Remains as Baseline, OR * The day when Urinary LH Surge is positive
Ultrasound guided Ovum Pick-Up is performed 34-36 hours after IVF-C (HCG 10000 IU) injection. Embryo Transfer is performed after 48-72 hours of incubation at 4-8 cell stage. Maximum of 2 embryos are transferred, using ultrasound guided transfer. Cancellation Criteria: * Poor patient compliance * Premature Ovulation * Premature LH Surge * Endometrium \< 7 mm * Poor Follicular Development * E2 Level \> 2,500 pg/ml
Sperm preparation through Swim-Up or Gradient is performed 1 hour prior to the oocyte retrieval; Fill the device without air bubble. Only 100000 motile spermatozoa are added into the device; After follicle aspiration, oocyte(s) are identified in the follicular fluid and immediately placed into the device; The device is closed, placed into a protective outer rigid shell and then positioned into the vaginal cavity for 2 to 3 days; No activity restriction is required for the patient, except baths. After 2 or 3 days of incubation, the retention system and the device are removed from the vagina in sterile environment. The device is opened and the contents are observed in a sterile environment under microscope to find the embryos. The two best quality embryos are loaded into embryo transfer catheter and transferred immediately unto the uterine cavity using aseptic techniques.