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

Last updated: March 22, 2021
Sponsor: Galaxy Pharma (Pvt) Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT01058252
GIVF-SRM 1001
  • Ages 20-37
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Tubal factor without Hydrosalpinx
  • Unexplained infertility with unsuccessful attempts in achieving pregnancy throughtimed 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

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

Study Design

Total Participants: 30
Study Start date:
May 01, 2021
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • Friends Ivf

    Faisalabad, Punjab
    Pakistan

    Site Not Available

  • Lady Wallington Hospital

    Lahore, Punjab
    Pakistan

    Active - Recruiting

  • Fertility Care Multan

    Multan, Punjab
    Pakistan

    Site Not Available

  • Ova IVF & Reproductive Health Clinics

    Karachi, Sindh 75300
    Pakistan

    Active - Recruiting

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