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

What Was Tested

The trial (phase 4) is built around Cetrorelix.

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.

It had two arms (groups): Control Group (A): (other) and Test Group (B): (experimental).

Cetrorelix acetate.

The registry classes the interventions as drug.

More on the Plan

Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles. 1.

Participants will receive the same monitoring and safety precautions as standard IVF patients.

Ethical Safeguards in Place: Participants will provide detailed informed consent, outlining all aspects of the protocol, including the use of approved medications and the lack of deviation from standard care. 2.

Prolutex is a water-soluble complex of natural progesterone with hydroxypropyl-β-cyclodextrin (HPBCD), patented as US Patent No. 4,727,064 (Pitha, J.), allowing for subcutaneous injection.

Who Took Part

The registry lists 230 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: poor responders (bologna criteria); stage iii-iv endometriosis; pituitary or hypothalamic dysfunction.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cetrorelix, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-01 with completion listed for 2026-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Primary Outcome: (time frame: 2 weeks within administration).

It also tracked 6 secondary outcomes, for example secondary outcomes, maturation rate, • Fertilization rate, • Blastocyst formation rate, • Duration of stimulation (in days) and • Hormonal profile (Luteinizing Hormone, Estradiol, Progesterone).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cetrorelix in 230 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.