BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-44
SponsorCentrum Clinic IVF Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ovulation Trigger Timing Based on Leading Follicle Size in POSEIDON Group 4 IVF Patients
Other interventionIn 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 6-8 months.Sponsors and contacts
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Source ClinicalTrials.gov