Follicular Size and Ploidy Observational Study

NCT04052035 | Unknown

• 1 other identifier: 1905-ABU-061-ND
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Follicle Size; Age, Parental

Keywords

follicle size; maturity; euploid

Outcome Measures

Primary Outcomes (1)

• Blastocyst ploidy outcome according to the follicular size at the OPU

  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

  2 months

Secondary Outcomes (13)

• Recovery rate

  2 months

• Maturate rate

  2 months

• Fertilization potential ( normal and abnormal fertilization)

  2 months

• Embryo development up to blastocyst stage

  2 months

• Embryo development in time lapse incubators

  2 months

Interventions

measuring the size of the follicle at time of follicle aspiration PROCEDURE

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

• Age: 18 Years - 40 Years
• Gender Eligibility Details: it depends on the ability to produce follicles
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

Location

Biospecimen

Retention: SAMPLES WITH DNA

trophectoderm cells

Study Officials

• Ibrahim Elkhatib, MSc

  IVIRMA Middle East Fertility Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant IVF Laboratory

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: February 10, 2020
• Primary Completion: June 30, 2023
• Study Completion: August 30, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Undecided
• Access Criteria: Undecided

Locations

AE (1)