Clinical trial NCT04052035: Follicular Size and Ploidy Observational Study
Official title: Follicular Size and Ploidy: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follicle Size
Age, Parental
Keywords: follicle size
maturity
euploid
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is eligible to all patients undergoing a fertility treatment with PGT-A analysis at the blastocyst stage

Brief summary: The primary objective is to determine which follicle sizes generate the highest rate of euploid blastocysts.

Detailed description: The primary objective is to determine which follicle sizes generate the highest rate of euploid blastocysts.

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.

Eligibility criteria: Inclusion Criteria:

Cycles with PGT-A analysis

* 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:

* Inability to puncture all follicles from one ovary
* 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

Primary outcomes:
measure: Blastocyst ploidy outcome according to the follicular size at the OPU
timeFrame: 2 months
Secondary outcomes:
measure: Recovery rate
timeFrame: 2 months
measure: Maturate rate
timeFrame: 2 months
measure: Fertilization potential ( normal and abnormal fertilization)
timeFrame: 2 months
measure: Embryo development up to blastocyst stage
timeFrame: 2 months
measure: Embryo development in time lapse incubators
timeFrame: 2 months
measure: Chromosomal status of biopsied embryos
timeFrame: 2 months
measure: mtDNA copy number
timeFrame: 2 months
measure: Miscarriage rate after single euploid embryo transfer
timeFrame: 2 months
measure: pregnancy rate after euploid embryo transfer
timeFrame: 2 months
measure: biochemical pregnancy rate
timeFrame: 2 months
measure: clinical pregnancy rate
timeFrame: 2 months
measure: implantation rate
timeFrame: 2 months
measure: ectopic pregnancy rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: IVIRMA Middle East Fertility Clinic
name: Ibrahim Elkhatib, MSc
role: STUDY_CHAIR
References: