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

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

Conditions

• Primary Infertility
• Secondary Infertility
• Low Responders
• Mild to Moderate Male Factor Infertility

Interventions

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.

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

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

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.

Sponsors & Collaborators

• Ova IVF & Reproductive Health Clinics, Karachi

  collaborator UNKNOWN

• Galaxy Pharma (Pvt) Limited

  lead INDUSTRY

Principal Investigators

• Dr Gul Rana, MBBS · Ova IVF & Reproductive Health Clinics

Eligibility

Min Age

20 Years

Max Age

37 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-31

Primary Completion

2021-12-31

Completion

2022-03-31

FDA Device

Yes

Countries

• Pakistan

Study Locations