Follicular Size and Ploidy: an Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- ART Fertility Clinics LLC
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Blastocyst ploidy outcome according to the follicular size at the OPU
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Blastocyst ploidy outcome according to the follicular size at the OPU
Time Frame: 2 months
Blastocyst ploidy is determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. A biopsy is only possible if an oocyte was retrieved from the follicle that was mature, normally fertilized and developed into a blastocyst of sufficient quality for biopsy). The following outcomes are possible: 1. Normal 2. Abnormal 3. Inconclusive/No result
Secondary Outcomes
- Recovery rate(2 months)
- Maturate rate(2 months)
- Embryo development in time lapse incubators(2 months)
- Miscarriage rate after single euploid embryo transfer(2 months)
- Fertilization potential ( normal and abnormal fertilization)(2 months)
- Embryo development up to blastocyst stage(2 months)
- ectopic pregnancy rate(2 months)
- Chromosomal status of biopsied embryos(2 months)
- mtDNA copy number(2 months)
- pregnancy rate after euploid embryo transfer(2 months)
- implantation rate(2 months)
- biochemical pregnancy rate(2 months)
- clinical pregnancy rate(2 months)
Investigators
Daniela Nogueira
Consultant IVF Laboratory
ART Fertility Clinics LLC