Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304900872465 Date of Approval: 03/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of injecting slowly motile sperms in Intra-cytoplasmic Sperm Injection cases with sex selection
Official scientific title Effect of injecting slowly motile sperms in Intra-cytoplasmic Sperm Injection cases with sex selection
Brief summary describing the background and objectives of the trial Background: Motivations for attempting sex selection can be broadly divided into two categories: medical and non-medical. The sex of embryos created by in vitro fertilization (IVF) can be diagnosed using PGD. In this study, we aim to compare injecting slowly motile sperms versus rapidly motile ones in PGD cases requesting sex selection for family balance.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied non
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/06/2022
Actual Last follow-up date 01/07/2022
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 132
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A we use sperms which has slow progressive motility for injecting the oocytes, the main issue here is the type of the sperm as regards motility 3 days incubation of the injected oocytes Induction and oocyte retrieval: females underwent controlled ovarian hyper-stimulation with gonadotropins using GnRH-antagonist or GnRH-agonist protocols. Serial monitoring by serum estradiol measurements and ultrasound examinations. When at least two follicles measured 18 mm in diameter, Human Chorionic Gonadotropin (HCG) (5000 - 10,000 IU intramuscularly) was administered, and trans-vaginal ultrasound guided oocyte retrieval was performed 36 hours later. Sample preparation and sperm selection: Samples were obtained after 3 days of sexual abstinence, by masturbation at laboratory and prepared by Swim-up procedure in HAM’s medium. For sperm microselection, 1 μL of the Swim-up sample was placed in a 5-μL drop of 10% polyvinylpyrrolidone (PVP; Origio, Denmark). Spermatozoa with normal morphology and slowly progressive motility were selected and used for ICSI In all cases, intracytoplasmic sperm injection (ICSI) was performed, injected oocytes were incubated in (Global Total) culture media which contains gentamycin sulfate and human serum albumin, under carbon dioxide and nitrogen condition adjusted at PH=7.3. All patients had embryo biopsy performed on Day 3 after oocyte retrieval, by direct aspiration of a single blastomere through the zona pellucida. Pre-implantation genetic diagnosis (PGD) regarding gender of the embryos were performed, nuclear DNA was analyzed by Fluorescent In Situ Hybridization (FISH) using a 2-chromosome (X, Y) probe. Patients were counseled about the results prior to embryo transfer on Day 5 of embryo development. 94
Control Group group B Spermatozoa with normal morphology and rapidly progressive motility were selected and used for ICSI,, here the main idea is the rapidly moving progressive sperms used for injecting oocyte for ICSI 3 days incubation of the injected oocytes Induction and oocyte retrieval: females underwent controlled ovarian hyper-stimulation with gonadotropins using GnRH-antagonist or GnRH-agonist protocols. Serial monitoring by serum estradiol measurements and ultrasound examinations. When at least two follicles measured 18 mm in diameter, Human Chorionic Gonadotropin (HCG) (5000 - 10,000 IU intramuscularly) was administered, and trans-vaginal ultrasound guided oocyte retrieval was performed 36 hours later. Sample preparation and sperm selection: Samples were obtained after 3 days of sexual abstinence, by masturbation at laboratory and prepared by Swim-up procedure in HAM’s medium. For sperm microselection, 1 μL of the Swim-up sample was placed in a 5-μL drop of 10% polyvinylpyrrolidone (PVP; Origio, Denmark). Spermatozoa with normal morphology and rapidly progressive motility were selected and used for ICSI In all cases, intracytoplasmic sperm injection (ICSI) was performed, injected oocytes were incubated in (Global Total) culture media which contains gentamycin sulfate and human serum albumin, under carbon dioxide and nitrogen condition adjusted at PH=7.3. All patients had embryo biopsy performed on Day 3 after oocyte retrieval, by direct aspiration of a single blastomere through the zona pellucida. Pre-implantation genetic diagnosis (PGD) regarding gender of the embryos were performed, nuclear DNA was analyzed by Fluorescent In Situ Hybridization (FISH) using a 2-chromosome (X, Y) probe. Patients were counseled about the results prior to embryo transfer on Day 5 of embryo development. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: couples seeking ICSI for sex selection because of non-medical causes (family balancing). age from 20-40 years old Exclusion criteria: female factor infertility (ovarian reserve, tubal factor, endometriosis, hormonal disturbances or karyotype alterations) male factor infertility (varicocele, hormonal disturbances, genitourinary infection or karyotype alterations). Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/01/2023 faculty of medicine Alexandria university ethics committe
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, Alexandria , Egypt Alexandria 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the percentage of male embryos in both groups after 5 days of fertilization
Secondary Outcome pregnancy rate in both groups. after 14 days of embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Engab fertility centre Syria street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
wael el gazayerili syria street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria university shatby street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator suzan elsharkawy samirsuzan6@gmail.com 00201090052715 wekala street
City Postal code Country Position/Affiliation
Damanhour Egypt assistant prof Alexandria university
Role Name Email Phone Street address
Public Enquiries mohamed khalil mohamed.hussein@alexmed.edu.eg 00201002375636 moharab bek street
City Postal code Country Position/Affiliation
Alexandria Egypt professor alexandria university
Role Name Email Phone Street address
Scientific Enquiries wael el gazayerli wael.elgazayerli1@gmai.com 00201298052726 syria street
City Postal code Country Position/Affiliation
Alexandria Egypt assistant professor Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). Informed Consent Form,Study Protocol Immediately following publication. No end date Researchers who provide a methodologically sound proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information