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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06433518
Other study ID # 2024-3-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date November 1, 2024

Study information

Verified date May 2024
Source Centrum Clinic IVF Center
Contact Emre G Pabuccu, Professor
Phone +90 532 4147844
Email emregpabuccu@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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. **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.


Description:

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: 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date November 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 44 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centrum Clinic IVF Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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