The prevention of premature luteinizing hormone (LH) surge during controlled ovarian stimulation (COS) is critical for optimizing outcomes in assisted reproductive technology (ART). Cetrorelix acetate, a GnRH (Gonadotropin releasing hormone) antagonist administered subcutaneously, is the current standard for luteinizing hormone suppression. However, natural progesterone in a novel subcutaneous formulation (Prolutex) may offer a viable alternative.
Prolutex is a water-soluble complex of natural progesterone with hydroxypropyl-β-cyclodextrin (HPBCD), patented as US Patent No. 4,727,064 Pitha, Jallowing for subcutaneous injection. This may simplify treatment and improve patient compliance.
Progesterone forms are well studied and used globally/in UAE to suppress Luteinizing Hormone surge. It is an example of off-label use, which becomes a standard indication for use of progesterone. Several studies have demonstrated that exogenous progesterone can effectively suppress Luteinizing Hormone release while maintaining follicular development and oocyte competence. Furthermore, progestin-based protocols are potentially more cost-effective and similar to administer compared to GnRH (Gonadotropin releasing hormone) antagonists.
To our knowledge, this is the first randomized trial directly comparing a subcutaneous progesterone formulation (Prolutex) with cetrorelix acetate, administered via the same route, in terms of luteinizing hormone surge suppression. For this specific research, there are no relevant published studies available. This Randomised controlled trial will be done to address the research gap and compare the two already approved standard of care medications to see if Prolutex can be used as a viable alternative to suppress Luteinizing Hormone levels.
Women aged 18-40 years.
Body Mass Index < 35 kg/m²
Antral Follicle Count ≥ 8 or Anti-Müllerian Hormone ≥ 1.2 ng/mL
Undergoing freeze-all IVF (for Ovarian Hyperstimulation Syndrome - OHSS risk, PGT- Preimplantation Genetic Testing, or personal preference)
Poor responders (Bologna criteria)
Stage III-IV endometriosis
Pituitary or hypothalamic dysfunction
Planned fresh embryo transfer
Parallel
Control Group (A):
DrugControl Group (A): Cetrorelix acetate 0.25 mg Subcutaneously daily from day 5 to trigger
Test Group (B):
Drugprolutex
Primary Outcome:
Ultrasound evidence of follicular rupture, including: 1. Disappearance or collapse of dominant follicles 2. Appearance of free fluid in the posterior cul-de-sac3. Absence of expected follicular structure
secondary outcomes
Number of oocytes retrieved
maturation rate
• MII oocyte rate
• Fertilization rate
fertilized number of m2 injected oocystes
• Blastocyst formation rate
number of embryos reaching blastocysts
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