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Trial · Interventional

Not yet recruitingPhase 4Registry data

Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles.

Short name IVF ART

NCTNCT07350317 (opens ClinicalTrials.gov in a new tab)Other idBH/REC/149/25
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
230 participants (estimated)
Sponsor
Trust Fertility Clinic · Other
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Jan 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
First posted
20 Jan 2026
Last update posted
20 Jan 2026
Conditions
Assisted Reproductive Techniques

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 4

    IVF ART

    NCT07350317

    est. Jan 2026 to est. Feb 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Control Group (A):Drug
  • Test Group (B):Drug

Arms2

  • Other

    Control Group (A):

    Cetrorelix acetate

  • Experimental

    Test Group (B):

    Natural progesterone 25 mg Subcutaneously (Prolutex) daily from day 5 to trigger

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Primary Outcome:

    Time frame · 2 weeks within administration

    Registry description

    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(6)

  1. secondary outcomes

    Time frame · 2 weeks after stimulation

    Registry description

    Number of oocytes retrieved

  2. maturation rate

    Time frame · 2 weeks after stimulation

    Registry description

    • MII oocyte rate

  3. • Fertilization rate

    Time frame · 2 days after egg collection

    Registry description

    fertilized number of m2 injected oocystes

  4. • Blastocyst formation rate

    Time frame · 3 weeks after stimulation

    Registry description

    number of embryos reaching blastocysts

  5. • Duration of stimulation (in days)

    Time frame · 10 to 14 days from start

    Registry description

    duration of stimulation in days

  6. • Hormonal profile (Luteinizing Hormone, Estradiol, Progesterone)

    Time frame · 2 weeks duration from start of stimulation

    Registry description

    numeric hormone level

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Women aged 18-40 years. 2. Body Mass Index \< 35 kg/m² 3. Antral Follicle Count ≥ 8 or Anti-Müllerian Hormone ≥ 1.2 ng/mL 4. Undergoing freeze-all IVF (for Ovarian Hyperstimulation Syndrome - OHSS risk, PGT- Preimplantation Genetic Testing, or personal preference) Exclusion Criteria: 1. Poor responders (Bologna criteria) 2. Stage III-IV endometriosis 3. Pituitary or hypothalamic dysfunction 4. Planned fresh embryo transfer 5. Severe Male Factor. Semen Count \<1 ×〖10〗\^6 (\<1 Million/ml) or Azoospermia)

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