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

NCT07350317 | Not Yet Recruiting Phase 4

• 1 other identifier: BH/REC/149/25
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Assisted Reproductive Techniques

Keywords

ivf protocol; prolutex; premature ovulation

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks within administration

Secondary Outcomes (6)

• secondary outcomes

  2 weeks after stimulation

• maturation rate

  2 weeks after stimulation

• • Fertilization rate

  2 days after egg collection

• • Blastocyst formation rate

  3 weeks after stimulation

• • Duration of stimulation (in days)

  10 to 14 days from start

Study Arms (2)

Control Group (A):

OTHER

Cetrorelix acetate

Drug: Control Group (A):

Test Group (B):

EXPERIMENTAL

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

Drug: Test Group (B):

Interventions

Control Group (A): DRUG

Control Group (A): Cetrorelix acetate 0.25 mg Subcutaneously daily from day 5 to trigger

Also known as: Cetrorelix acetate 0.25 mg Subcutaneously daily from day 5 to trigger o

Control Group (A):

Test Group (B): DRUG

prolutex

Also known as: Natural progesterone 25 mg Subcutaneously (Prolutex) daily from day 5 to trigger

Test Group (B):

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: females undergoing ovarian stimulation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Trust Fertility Clinic: lead

Related Publications (1)

• 1. Griesinger G, et al. Reprod Biol Endocrinol. 2016;14(1):29 2. Fatemi HM, et al. Hum Reprod. 2019;34(7):1223-34 3. Vuong LN, et al. Fertil Steril. 2021;116(5):1148-57 4. Papanikolaou EG, et al. J Assist Reprod Genet. 2020;37(4):841-50 5. Pitha J. US Patent No. 4,727,064

  BACKGROUND

MeSH Terms

Interventions

Control Groups; cetrorelix

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

ahmed elbohoty Elbohoty, professor

CONTACT

00971504067530; elbohoty79@gmail.com

Amani Kanan Kanan, specialist obstetrics and gyny

CONTACT

00971564558401; AMANIINEM@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor consultant ART

Model Details: * Design: Prospective, Phase IV, randomized, open-label, non-inferiority trial * Setting: Trust Fertility Clinic, Abu Dhabi, UAE * Randomization: 1:1 block randomization, stratified by age and ovarian reserve * Arms: * Control Group (A): Cetrorelix acetate 0.25 mg Subcutaneously daily from day 5 to trigger * Test Group (B): Natural progesterone 25 mg Subcutaneously (Prolutex) daily from day 5 to trigger

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share