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.: PACTR202401759325189 Date of Approval: 16/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Myo-Inositol-in combination with alpha-lipoic acid and cysteine (Celine) based co-treatment on Oocyte Quality in Women with Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
Official scientific title Effect of Myo-Inositol-in combination with alpha-lipoic acid and cysteine (Celine) based co-treatment on Oocyte Quality in Women with Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
Brief summary describing the background and objectives of the trial Background: Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myoinositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myoinositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). Myoinositol is classified as a component of the B complex vitamin, and is synthesized from glucose in the human body. It plays an important role in gamete development, oocyte maturation, fertilization, and embryonic development. Objectives: Primary objectives: Evaluate the effect of Myo-Inositol, in combination with alpha-lipoic acid and N-acetylcysteine, (CelineTM) as an adjunct to ovarian stimulation on oocyte performance measures in infertile women with PCOS undergoing IVF (oocyte yield, maturation and fertilization rates). Secondary objectives: Evaluate the effect of Myo-Inositol, in combination with alpha-lipoic acid and N-acetylcysteine, on the number of gonadotropin ampules consumed, number of stimulation days, embryo quality and pregnancy rates.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 02/01/2019
Actual trial start date 02/01/2019
Anticipated date of last follow up 28/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Folic acid 400 μg Intervention began 6 weeks prior to stimulation and continued during ovarian stimulation until the day of final oocyte maturation Control group received 400 μg of folic acid. 50 Placebo
Experimental Group Celine TM Celine TM twice daily Intervention began 6 weeks prior to stimulation and continued during ovarian stimulation until the day of final oocyte maturation. Intervention group received Celine TM which is a combination of myoinositol,alpha-lipoic acid and N-acetylcysteine twice daily in addition in addition to 400 μg FA 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Women aged 20-40 years at the time of enrollment - diagnosed with PCOS (according to the Rotterdam criteria, represented by oligomenorrhea, hyperandrogenism or hyperandrogenemia, and typical ovarian features on ultrasound), - and undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) treatment. - Normal uterine cavity as assessed by hysteroscopy or hysterosalpingography and normal prolactin and thyroid-stimulating hormone levels were required. Women with male factor infertility, such as azoospermia Women with other medical conditions causing ovulatory dysfunction, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia. 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 20/08/2018 Ethics committee in Albayda fertility centre
Ethics Committee Address
Street address City Postal code Country
Albayda Albayda 00000 Libyan Arab Jamahiriya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures were oocyte parameters, including preovulatory follicle count, which reflects the number of preovulatory follicles >17mm in size, total number of oocytes retrieved, which typically ranges from 6 to 15; oocyte quality, defined by the number of MII oocytes retrieved; and the number and quality of embryos transferred, based on the number of morphologically Grade 1 embryos. The day of final oocyte maturation
Secondary Outcome Secondary outcomes included duration of ovarian stimulation, number of gonadotropin vials used reflecting total gonadotropin dose, and pregnancy based on ultrasound. At the beginning and at the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Teaching Assistance Reproductive Technology Hospital Al Andalus street Benghazi Libyan Arab Jamahiriya
FUNDING SOURCES
Name of source Street address City Postal code Country
Jehan Elfarjani Al Andalus street Benghazi Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jehan Elfarjani Al Andalus street Benghazi Libyan Arab Jamahiriya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Patrick Choueiry Patrick@surveal.com +9611888083 Jdeideh main road, R.O Square 1 Center
City Postal code Country Position/Affiliation
Jdeideh Lebanon Global Medical Director at Surveal
Role Name Email Phone Street address
Scientific Enquiries Patrick Choueiry Patrick@surveal.com +9611888083 Jdeideh main road, R.O Square 1 Center
City Postal code Country Position/Affiliation
Jdeideh Lebanon Global Medical Director at Surveal
Role Name Email Phone Street address
Principal Investigator Jehan Ilfargani jelfarjani@yahoo.com +218925439322 Saba Street House No.5
City Postal code Country Position/Affiliation
Benghazi Libyan Arab Jamahiriya Deputy Director of Benghazi Teaching Hospital for Assisted Reproductive Technique
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 deidentification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis. Approval of the request by the principal investigator is prerequisite to the sharing of data with the requesting party. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information