UnknownNot Applicable

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

Pakistan30 participantsStarted 2021-05

Plain-language 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

Who can participate

Age range

20 Years – 37 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Quarterly

Trial details

NCT IDNCT01058252

SponsorGalaxy Pharma (Pvt) Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12

Contact for this trial

Dr Gul Rana, MBBS

+923353039246 gulrana8@gmail.com

View on ClinicalTrials.gov More Primary Infertility trials

Who can participate

Age range

20 Years – 37 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.