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

March 22, 2021 updated by: Galaxy Pharma (Pvt) Limited

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Lady Wallington Hospital
        • Contact:
          • Prof. Ayesha Malik
          • Phone Number: +923008488644
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Recruiting
        • Ova IVF & Reproductive Health Clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

IVF Network Centers across the country, selecting patients meeting inclusion and exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Letrozole, recFSH, INVOCell, Monitoring
Infertile couple following MSP with INVO IVF
Combination product: INVOCell, Letrozole 2.5 mg, recFSH 75 IU

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.
Other Names:
  • Aromek (Letrozole 2.5 mg);
  • Follitrope (Recombinent FSH - 75 IU)
  • IVF-C 5000 IU (HCG)
  • Ova-Surge (Urinary LH Surge Kit)
  • Indomethacin 50 mg
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:

  • 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
Other Names:
  • 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.

Cancellation Criteria:

  • Poor patient compliance
  • Premature Ovulation
  • Premature LH Surge
  • Endometrium < 7 mm
  • Poor Follicular Development
  • E2 Level > 2,500 pg/ml
Other Names:
  • Ovum Pick-Up
  • Embryo Transfer
  • Ultrasound Guided
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 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.
Other Names:
  • INVOCell
  • Diaphragm (Retention Device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Follicles >18 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate
Time Frame: Quarterly
Quarterly

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Rate; Cost of Treatment
Time Frame: Every 6 months
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galaxy Pharma (Pvt) Limited

Collaborators

Ova IVF & Reproductive Health Clinics, Karachi

Investigators

  • Study Director: Dr Gul Rana, MBBS, Ova IVF & Reproductive Health Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIVF-SRM 1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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