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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 to 37 years
• All sexes
• Healthy volunteers accepted
• Adult

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

Trial locations and contacts

2 sites in 1 country.

About this study

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

Conditions

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

Being tested

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• INVOCell, Letrozole 2.5 mg, recFSH 75 IUCombination product

  Also called Aromek (Letrozole 2.5 mg);, Follitrope (Recombinent FSH - 75 IU), IVF-C 5000 IU (HCG), Ova-Surge (Urinary LH Surge Kit)

  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.

• STEP-3: LH Suppression & MonitoringProcedure or surgery

  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.

• STEP-4: HCG TimingProcedure or surgery

  Also called IVF-C 5000 IU

  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

• STEP-5: OPU, ET, CancellationProcedure or surgery

  Also called Ovum Pick-Up, Embryo Transfer, Ultrasound Guided

  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

• INVOCell (Intravaginal Culturing)Procedure or surgery

  Also called INVOCell, Diaphragm (Retention Device)

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Follicles >18 mm on the day of HCG; Number of Oocytes aspirated; Fertilisation Rate

   Measured: Quarterly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jan 2010 (estimated)
2. Study startMay 2021 (estimated)
3. Primary completionDec 2021 (estimated)
4. Study completionMar 2022 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (23)Papers the sponsor has linked to this study.
• Other trials for Primary InfertilityStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.