Clinical trial

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

Name

2024-3-1

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2024-10-01

Trial end

2024-11-01

Status

Not yet recruiting

Treatment

recombinant hCG

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.

Arms:

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

Size

140

Primary endpoint

Change in the Mean Mature Oocytes between two triggering strategies

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

Eligibility criteria

Inclusion Criteria: Women age \>35 years Women with low serum AMH (\<1,2 ng/ml), low AFC (\<5) Undergoing assisted reproduction with Short antagonist protocol Max daily gonadotropin dose of 300 IU Exclusion Criteria: * women with uterine and/or endometrial abnormality, women with endometrioma(s), short or long GnRH-agonist ovarian stimulation protocols, severe male infertiliy, genetic conditions, with normal ovarian reserve markers, \<35 years old, women with prior ovarian surgeries, PGT-a cycles

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '6 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

Updated at

2024-05-30

1 organization

1 product

1 indication

Organization

Centrum Clinic IVF Center

Product

recombinant hCG

Indication

In Vitro Fertilization