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.: PACTR201911748191910 Date of Registration: 07/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimal Time Interval Between Final Follicular Triggering and Ovum Pickup in ICSI Cycle
Official scientific title Optimal Time Interval Between Final Follicular Triggering by Human Chorionic Gonadotropin and Ovum Pickup and Outcome of Gonadotropin Releasing Hormone Antagonist ICSI Cycles
Brief summary describing the background and objectives of the trial Background: During the time interval between HCG administration and ovum pickup some important events are triggered by the LH activity of HCG as the initiation of luteinization of granulosa cells, the expansion of cumulus cells leading to the dissociation of the cumulus–oocyte–complex (COC) from the follicular wall and the resumption of oocyte meiotic maturation. There are many factors that may influence ART outcomes by affecting follicular development, oocyte maturation, fertilization and embryo development subsequently. The effect of these factors depends on HCG priming time. objectives: The aim of this work is to correlate the time interval between HCG triggering and ovum pickup with oocytes yield, maturation and quality in GnRH antagonist ICSI cycles.
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 Fertility-female
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 30/11/2019
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Human chorionic gonadotropin HCG then ovum pickup after 34 hours 250 μg of recombinant HCG (Ovitrelle, Merck Serono Europe Ltd, London, UK) administrated then ovum pickup after 34 hours ovum pickup after 34 hours after HCG administration 150
Control Group Human Chorionic gonadotropin then ovum pickup after 35 hours and 36 hours 250 μg of recombinant HCG (Ovitrelle, Merck Serono Europe Ltd, London, UK) ovum pick up will be performed after 35 & 36 hours control group 1: Ovum pickup will be performed after 35 hours of HCG administration control group 2: Ovum pickup will be performed after 36 hours of HCG administration 250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women aged 20 – 35 years with expected normal response to the standard controlled ovarian stimulation undergo ICSI for any cause of infertility. 1. Cases of polycystic ovaries syndrome (PCOS). 2. Women with history of ovarian hyper-response and/or OHSS in previous ICSI cycle. 3. Women with history of poor ovarian response according to Bologna criteria. 4. Antimullerian hormone level either < 1.1 ng/dl or > 4.0 ng/dl. 5. Surgically retrieved sperms. 6. Untreated hydrosalpinges. 7. Congenital uterine abnormalities. Adult: 19 Year-44 Year 20 Year(s) 35 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 24/10/2019 Ethics committee of faculty of medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine, 17 Champollion st., El Messalah, Alexandria, Egypt Alexandria 215921 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Oocyte retrieval rate: the ratio of the number of cumulus–oocyte–complex (COC) retrieved to the number of follicles ≥15 mm present on the day of HCG priming. • Percentage of M II oocytes: metaphase II oocytes were defined by the presence of first polar body and round ooplasm. after ovum pickup
Secondary Outcome • Oocyte morphological abnormalities. • Fertilization rate: defined as the mean number of two pronuclear (2PN) zygotes divided by MII-aspirated oocytes. • Blastocyst rate: defined as the number of blastocysts (day 5/6 embryos) divided by MII- aspirated oocytes. • Embryos quality & grading: cleavage stage embryo and blastocysts will be graded according to corresponding scaling systems. • Implantation rate: calculated as the number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos. • Clinical pregnancy rate: calculated by considering clinical pregnancy, determined by the visualization of a viable gestational sac within the uterine cavity by ultrasound 3– 4 weeks after embryo transfer. • Ongoing pregnancy rate: defined as pregnancy progressing beyond 12 weeks gestation. • OHSS incidence: women who will develop OHSS will be classified according to severity into mild, moderate, severe and critical OHSS. every second outcome will be checked on the appropriate time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El Khousoba infertility center 1 Fawzy Moaaz St. Alexandria 21647 Egypt
Agial infertility Center Alferid lyan St, Roushdy off of Syria St. Alexandria 21529 Egypt
El Madina IVF center 25 El-Shaheed Kamal El-Deen Salah, Ezbet Saad, Sidi Gaber, Alexandria Governorate Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Shoukry Abd ElMoneim Mohamed 1 Hedaya Basha street, Gleem, Alexandria, Egypt Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of obstetrics and Gynecology Faculty of medicine Alexandria University Elshatby University Hospital, ElShatby, Alexandria, Egypt Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Department of obstetrics and gynecology faculty of medicine Alexandria University Elshatby University Hospital, Elshatby Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Shoukry joy_weak@yahoo.com 0201024586399 1 Hedaya Basha St. Gleem
City Postal code Country Position/Affiliation
Alexandria Egypt Teaching Assistant Faculty of medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ashraf Haneaa Abd ElRahman ashrafhany3000@yahoo.com 0201222589219 ElShatby University Hospital, Elshatby , ALexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Elmahdy mahdy_moh@yahoo.com 0201002413531 Elshatby University hospital, Elsahtby, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Reproductive endocrinology and infertility
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all collected IPD will be available Clinical Study Report,Informed Consent Form,Study Protocol starting 6 months after publication and for 6 month Open
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