BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)

NCT06433518 | Recruiting

• 1 other identifier: 2024-3-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve. For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:

1. 1.\*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
2. 2.\*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.

Conditions

Fertilization; Fertilization in Vitro

Keywords

oocyte; IVF; poor responder; ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Change in the Mean Mature Oocytes between two triggering strategies

  Mean numbers of oocytes, mature oocytes, fertilization rates, embryos and pregnancy rates will be compared between two different triggering sizes.

  From enrollment to the end of treatment at 6-8 months.

Study Arms (1)

Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF

This group of women, who have low serum AMH levels and low antral follicle count obviusly reveal unfavorable ovarian stimulation and reproductive outcomes in daily practice. Since the most important outcome measure is the live birth rate in assisted reproduction, rates have been reportedly very low for this cohort. Depending from the reports, live birth rates particularly cumulative rates directly correlated with collected numbers of oocytes. Therefore, studies should focus on this entity.

Other: Ovulation Trigger Timing Based on Leading Follicle Size in POSEIDON Group 4 IVF Patients

Interventions

Ovulation Trigger Timing Based on Leading Follicle Size in POSEIDON Group 4 IVF Patients OTHER

In this study, ovulation trigger timing is determined according to the diameter of the leading follicle measured by transvaginal ultrasound during ovarian stimulation in women classified as POSEIDON group 4. Patients undergoing controlled ovarian stimulation are monitored with serial ultrasound examinations and serum hormone measurements. Ovulation triggering is performed when the leading follicle reaches predefined size categories. The study evaluates the association between the diameter of the leading follicle at the time of trigger and reproductive outcomes. The primary outcome measure is the number of metaphase II (MII) oocytes retrieved, while secondary outcomes include blastocyst formation and pregnancy outcomes.

Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF

Eligibility Criteria

• Age: 35 Years - 44 Years
• Gender Eligibility Details: Women with diminished ovarian reserve undergoing assisted reproduction.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A group of women defined as Poseidon Group 4, who will apply to the infertility clinic to be scheduled for ovarian stimulation and assisted conception treatments during the study period.

You may qualify if:

• Women age equal to or greater than 35 years
• Women with low serum AMH (\<1,2 ng/ml),
• women with low AFC (\<5)
• women Undergoing assisted reproduction with Short antagonist protocol or long -agonist protocol
• women who used Max daily gonadotropin dose of 300 IU

You may not qualify if:

• Age \<35 years.
• Ovarian reserve parameters not meeting the POSEIDON group 4 definition.
• Natural or modified natural cycles without controlled ovarian stimulation.
• In vitro maturation (IVM) cycles.
• Luteal-phase stimulation or DuoStim protocols.
• Preimplantation genetic testing (PGT-A, PGT-M, or PGT-SR) cycles, unless prespecified for stratified analyses.
• Major untreated uterine cavity pathology (e.g., submucosal fibroids, significant intrauterine adhesions, congenital uterine anomalies) or untreated hydrosalpinx.
• Cycles with missing or incomplete follicular measurement data on the trigger day.
• Cycles with non-standardized or undocumented trigger-to-oocyte retrieval intervals.

Sponsors & Collaborators

• Centrum Clinic IVF Center: lead

Study Sites (1)

Centrum Clinic IVF Center

Ankara, Ankara, 06800, Turkey (Türkiye)

RECRUITING

Study Officials

• Emre Pabuccu, Prof.

  Ufuk University

  STUDY DIRECTOR

Central Study Contacts

Emre G Pabuccu, Professor

CONTACT

+90 532 4147844; emregpabuccu@gmail.com

Recai Pabuccu, Professor

CONTACT

+90 532 6160086; pabuccu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)