Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF (MSP-IVC)
|ClinicalTrials.gov Identifier: NCT01058252|
Recruitment Status : Unknown
Verified February 2011 by Galaxy Pharma (Pvt) Limited.
Recruitment status was: Recruiting
First Posted : January 28, 2010
Last Update Posted : February 8, 2011
|Condition or disease||Intervention/treatment|
|Primary Infertility Secondary Infertility Low Responders Mild to Moderate Male Factor Infertility||Drug: Letrozole 2.5 mg, recFSH 75 IU Procedure: STEP-3: LH Suppression & Monitoring Procedure: STEP-4: HCG Timing Procedure: STEP-5: OPU, ET, Cancellation Procedure: INVOCell (Intravaginal Culturing)|
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|
|Estimated Enrollment :||100 participants|
|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 Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||February 2012|
Letrozole, recFSH, IVC, Monitoring
Infertile couple following MSP with IVC
Drug: Letrozole 2.5 mg, recFSH 75 IU
In previous cycles, cycle length and ovulatory status must be assessed and documented.
STEP 1: ANOVULATION by ORAL CONTRACEPTION
STEP 2: STIMULATION and MONITORING Day one of the cycle equals the first day of bleeding (not spotting).
Procedure: STEP-3: LH Suppression & Monitoring
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.
Procedure: STEP-4: HCG Timing
IVF-C (HCG 10000 IU) shall be injected to trigger the ovulation, when any of the following occur:
Other Name: IVF-C 5000 IU
Procedure: STEP-5: OPU, ET, Cancellation
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.
Procedure: INVOCell (Intravaginal Culturing)
Sperm preparation through Swim-Up or Gradient is performed 1 hour prior to the oocyte retrieval; Fill the device without air bubble. Only 30000 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.
- Number of Follicles >15 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058252
|Contact: Prof. Claude Ranoux, MD||978 email@example.com|
|Contact: Saif Ur Rehman||0092 323 firstname.lastname@example.org|
|Faisalabad, Punjab, Pakistan|
|Contact: Dr. Samina Khalid, MCPS, FCPS 0092 300 8664227|
|Sub-Investigator: Dr. Samina Khalid, MCPS, FCPS|
|Fertility Care Multan||Recruiting|
|Multan, Punjab, Pakistan|
|Contact: Prof. Samee Akhtar 0092 300 8637070|
|Principal Investigator: Prof. Samee Akhtar, FCPS, FRCOG|
|Sub-Investigator: Talha Mabood Paracha, Embryologyst|
|Galaxy IVF Limited||Recruiting|
|Karachi, Sindh, Pakistan, 75300|
|Contact: Saif Ur Rehman 0092 323 2440710 email@example.com|
|Contact: Talha Mabood Paracha, Embryologyst|
|Sub-Investigator: Talha Mabood Paracha, Embryologyst|
|American IVF & Pregnancy Center||Recruiting|
|Karachi, Sindh, Pakistan|
|Contact: Dr. Asma Munir, MCPS, FCPS|
|Contact: Pervaiz Masood Khan|
|Principal Investigator: Prof. Claude Ranoux, MS, MD|
|Study Chair:||Prof. Claude Ranoux, MD||INVOBioscience, USA|