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NCT Number: NCT06433518

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

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

All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.

The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.

Primary and secondary outcomes will be compared between the two groups.

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Key information

Age range

35 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Centrum Clinic IVF Center

Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Emre Pabuccu

CONTACT

05324147844

About this study

The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic.

However, a key issue is determining the most optimal timing for this trigger. In standard practice, the final triggering is performed when the follicle size reaches 17 mm or more.

The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process.

However, in some special cases, to maximize the desired yield, this size threshold may be adjusted.

A prime example of this is in older patients with poor ovarian reserve, as the expected egg yield may not be achieved with standard practices.

During the oocyte collection process, fewer mature oocytes (M2) may be retrieved, or no oocytes may be retrieved at all, despite proper ovarian stimulation. Therefore, the optimal follicle size for these cases has not been definitively established in the literature. Thus, there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields.

For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:

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

All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.

The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.

Primary and secondary outcomes will be compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in the Mean Mature Oocytes between two triggering strategies

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emre G Pabuccu, Professor

CONTACT

[email protected]

+90 532 4147844

Recai Pabuccu, Professor

CONTACT

[email protected]

+90 532 6160086

Sponsors and collaborators

Lead sponsor

Centrum Clinic IVF Center

Other

Registry information

Official study title

What Should Be The Optimal Ovulation Triggering Size in Poseidon Group 4 Patients Undergoing Ovarian Stimulation?

Acronym: BEST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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