Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
24 participants
OBSERVATIONAL
2020-02-10
2023-08-30
Brief Summary
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Detailed Description
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Secondary objectives to be analysed between the different follicle sizes:
* The number of cumulus oocyte complexes (COCs) retrieved per aspirated follicle size
* The number of mature oocytes per COC retrieved (maturation rate)
* The number of normally fertilized oocytes per number of oocytes injected (fertilization rate)
* Embryo development up to the blastocyst stage
* Chromosomal status of the biopsied blastocysts
* Pregnancy rates after euploid blastocyst transfer
* Miscarriage rate after euploid blastocyst transfer
Most of the studies that looked at the relation between the follicular size and the developmental competence of the corresponding oocyte analysed normal responders with an average age of 35 years and normal BMI levels. However, during the last decades, a clear shift appeared in the patient population that present themselves for a fertility treatment. With many women delaying childbirth, we do not yet know how these advanced maternal age women may benefit from early or late trigger or from different follicular sizes.
Also, the rising prevalence of obesity may impact the follicular growth, which has not been analysed at the individual follicle size before.
For the above described reasons, we believe that the analysis of individual follicles and the developmental competence of the obtained oocyte, may guide us to improve individualized stimulation protocols for different subtypes of infertile patients. To guide us in this individualized process, this initial pilot study will be performed in a population of normal responders and will later be expanded to an infertile population with different characteristics.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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measuring the size of the follicle at time of follicle aspiration
While for an OPU out of the study the follicles are aspirated without measuring their sizes, now the follicles will be measured before they are aspirated. The measurement of the follicles is a non- invasive measurement: as the OPU is always performed under vaginal echo-guidance, the follicles are visible on the screen connected to the vaginal echo probe. By measuring two dimensions of the follicle, an average follicle diameter is registered for that follicle
Eligibility Criteria
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Inclusion Criteria
* ICSI (intracytoplasmic sperm injection) only
* ICSI 40 hours after trigger
* Fresh oocytes
* Ejaculates: fresh or frozen: normozoospermia
* BMI ≤ 35kg/m 2
* Age ≤ 40 years
* AMH ≥ 1.1 ng/ml
* the number of follicles at the day of trigger: max 20 ≥ 11mm
* Stimulation protocol: Antagonist protocol with Menopur and and Dual trigger of (5.000-10.000IU) hCG and (0.2-0.3 mg) Gonapeptyl
* Final oocyte maturation trigger when 2-3 follicles reach size 17mm
* All races
* Embryo development in the Embryoscope with Global Total media
Exclusion Criteria
* Endometriosis
* Hydrosalpinx
* History of uterine surgery
* History of previous treatment which may impact the ovarian reserve (adnexal surgery,
* chemotherapy, radiation…)
* Time between trigger and pick up deviating from 36 hours
* \< 100.000 motile sperm
* Last follicular measurement day deviates more than 24 hours from the trigger day
18 Years
40 Years
FEMALE
No
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Daniela Nogueira
Consultant IVF Laboratory
Principal Investigators
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Ibrahim Elkhatib, MSc
Role: STUDY_CHAIR
IVIRMA Middle East Fertility Clinic
Locations
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IVI Middle East Fertilty Clinic
Abu Dhabi, , United Arab Emirates
Countries
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Other Identifiers
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1905-ABU-061-ND
Identifier Type: -
Identifier Source: org_study_id
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