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Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF

Information source: Galaxy Pharma (Pvt) Limited
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Infertility; Secondary Infertility; Low Responders; Mild to Moderate Male Factor Infertility

Intervention: Letrozole 2.5 mg, recFSH 75 IU (Drug); STEP-3: LH Suppression & Monitoring (Procedure); STEP-4: HCG Timing (Procedure); STEP-5: OPU, ET, Cancellation (Procedure); INVOCell (Intravaginal Culturing) (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Galaxy Pharma (Pvt) Limited

Official(s) and/or principal investigator(s):
Prof. Claude Ranoux, MD, Study Chair, Affiliation: INVOBioscience, USA

Overall contact:
Prof. Claude Ranoux, MD, Phone: 978 878-9505, Email: clauderanoux@invobioscience.com

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

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Follicles >15 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate

Secondary outcome: Pregnancy Rate; Cost of Treatment

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

Minimum age: 20 Years. Maximum age: 37 Years. Gender(s): Both.

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

Locations and Contacts

Prof. Claude Ranoux, MD, Phone: 978 878-9505, Email: clauderanoux@invobioscience.com

Friends Ivf, Faisalabad, Punjab, Pakistan; Recruiting
Dr. Samina Khalid, MCPS, FCPS, Phone: 0092 300 8664227
Dr. Samina Khalid, MCPS, FCPS, Sub-Investigator

Fertility Care Multan, Multan, Punjab, Pakistan; Recruiting
Prof. Samee Akhtar, Phone: 0092 300 8637070
Prof. Samee Akhtar, FCPS, FRCOG, Principal Investigator
Talha Mabood Paracha, Embryologyst, Sub-Investigator

American IVF & Pregnancy Center, Karachi, Sindh, Pakistan; Recruiting
Dr. Asma Munir, MCPS, FCPS
Pervaiz Masood Khan
Prof. Claude Ranoux, MS, MD, Principal Investigator

Galaxy IVF Limited, Karachi, Sindh 75300, Pakistan; Recruiting
Saif Ur Rehman, Phone: 0092 323 2440710, Email: saifrehman@galaxyivf.com
Talha Mabood Paracha, Embryologyst
Talha Mabood Paracha, Embryologyst, Sub-Investigator

Additional Information

Related publications:

Hewitt J. Intravaginal culture: present and potential uses. Br J Hosp Med. 1990 Sep;44(3):182, 184-5, 188. Review.

Starting date: February 2011
Last updated: February 6, 2011

Page last updated: November 27, 2014

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