Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles.
Starting soon · Phase 4
Conditions studied: Assisted Reproductive Techniques
In brief
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.
Key facts
- Study ID
- NCT07350317
- Run by
- Trust Fertility Clinic
- People needed
- 230
- Starts
- 2026-01-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Poor responders (Bologna criteria)
- Stage III-IV endometriosis
- Pituitary or hypothalamic dysfunction
- Planned fresh embryo transfer
- Severe Male Factor. Semen Count <1 ×〖10〗\^6 (<1 Million/ml) or Azoospermia)
Full record on ClinicalTrials.gov
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