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.: PACTR202509701842999 Date of Registration: 10/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Extended Letrozole Protocol versus Letrozole-Inositol Combination for Ovulation Induction in Letrozole-Resistant Polycystic Ovary Syndrome Women
Official scientific title Extended Letrozole Protocol versus Letrozole-Inositol Combination for Ovulation Induction in Letrozole-Resistant Polycystic Ovary Syndrome Women
Brief summary describing the background and objectives of the trial Letrozole is a first-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS). However, a subset of women exhibits resistance to conventional letrozole protocols. This study aimed to compare the efficacy of the extended letrozole protocol (ELP) versus the letrozole-inositol combination (ILC) for ovulation induction in letrozole-resistant PCOS women.
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 Treatment: Drugs
Anticipated trial start date 01/01/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 01/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extended Letrozole Protocol A maximum letrozole dose (7.5 mg) Daily, starting on cycle day 2 for 7 consecutive days. Extended Letrozole Protocol 100
Control Group Inositol Letrozole Combination 2 grams of inositol twice daily for three months, and during the final treatment cycle, letrozole (5 mg/day) was administered for five days starting on cycle day 2 to induce ovulation. 2 grams of inositol twice daily for three months, and during the final treatment cycle, letrozole (5 mg/day) was administered for five days starting on cycle day 2 to induce ovulation. 2 grams of inositol twice daily for three months, and during the final treatment cycle, letrozole (5 mg/day) was administered for five days starting on cycle day 2 to induce ovulation. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged between 18-35 years and diagnosed with PCOS who were seeking conception and presented at the outpatient’s infertility clinic of our department were eligible for initial evaluation. Eligibility criteria included a confirmed diagnosis of PCOS according to Rotterdam criteria [16], ovulation resistance to letrozole (no dominant follicles [>17mm] on mid cycle transvaginal ultrasound after a maximum letrozole dosing of 7.5 mg /day for 5 cycle days starting from cycle day 2) [17], a Body Mass Index (BMI) less than or equal 30 kg/m2, and a normal Hysterosalpingography (HSG) and/or diagnostic laparoscopy. Reasons for exclusion include women with endocrine disorders (e.g., active thyroid disease, adult-onset adrenal hyperplasia, diabetes, hyperprolactinemia, or adrenal-related hyperandrogenism), those concurrently using insulin-sensitizing medications like metformin, individuals with contraindications to pregnancy, and those with conditions that preclude inositol use, such as chronic liver or kidney disease. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 25/12/2023 Kafr Elsheikh ethical committee
Ethics Committee Address
Street address City Postal code Country
El Gish St, Qism Kafr El-Shaikh, Kafr Al Sheikh First, Kafr El-Sheikh Governorate Kafr Elsheikh 6860404 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study’s primary outcome was ovulation rate measured via TVUS every two days after the last letrozole dose to track follicular development and endometrial thickness until ovulation was confirmed. Confirmed ovulation was deemed when one follicle reached 18–20 mm in diameter. every two days after the last letrozole dose
Secondary Outcome Secondary outcomes included clinical pregnancy rate (detection of an intrauterine gestational sac by a TVUS), endometrial thickness (measured on mid-cycle using TVUS), and the incidence of Ovarian Hyperstimulation Syndrome (OHSS) as an adverse event. measured on mid-cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatients clinics of the department of obstetrics and gynecology in Kafr Elsheikh University Hospital El Gish St, Qism Kafr El-Shaikh, Kafr Al Sheikh First, Kafr El-Sheikh Governorate Kafr Elsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Soliman 6 Al-Ashkar St., Mansoura Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None None None None Egypt None
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Soliman drahmedsoliman1998@std.mans.edu.eg +201550071055 6 Al Ashqar St., off El Gomhouria St., Mansoura - Dakahlia - Egypt.
City Postal code Country Position/Affiliation
Manosura 35511 Egypt Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Eric Broni eric.broni@yale.edu 00201091012731 New Haven, CT
City Postal code Country Position/Affiliation
New Haven United States of America YALE UNIVERSITY SCHOOL OF MEDICINE
Role Name Email Phone Street address
Public Enquiries Ahmed Soliman ahmedsolimann9090@gmail.com +201550071055 6 Al Ashqar St., off El Gomhouria St., Mansoura - Dakahlia - Egypt.
City Postal code Country Position/Affiliation
Mansoura Egypt Faculty of Medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) Sharing Statement Study Title: Extended Letrozole Protocol versus Letrozole-Inositol Combination for Ovulation Induction in Letrozole-Resistant Polycystic Ovary Syndrome Women Sponsor: None (Investigator-initiated study) Principal Investigator: Ahmed Soliman Introduction: The Principal Investigator, Ahmed Soliman, is committed to the principles of open science and data sharing to advance medical knowledge, promote transparency, and avoid duplication of research efforts. In accordance with these principles and applicable regulations, we intend to share anonymized Individual Participant Data (IPD) from this clinical trial. Data to be Shared: Sep 1, 2025 Anonymized IPD, including but not limited to, patient-level clinical trial data, will be made available upon request. This will include: De-identified demographic information. Baseline characteristics. Data on interventions (Letrozole protocol, Letrozole-Inositol combination). Efficacy outcomes (e.g., ovulation rates, pregnancy rates). Safety outcomes and adverse events. Relevant laboratory and clinical measurements. Rationale for Sharing: The data will be shared to enable qualified researchers to: Re-analyze the study's findings for validation. Conduct new research questions and meta-analyses. Combine data with other studies to generate new insights. Anonymization and Confidentiality: All shared data will be fully anonymized to protect the privacy and confidentiality of the study participants. Direct and indirect identifiers will be removed or pseudonymized in a manner that ensures the impossibility of re-identifying any individual. The data will be shared only after all study results have been published in a peer-reviewed journal. Study Protocol From March 2025 to March 2026 Mentioned in the statement.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 10/09/2025 PACTR Admin Women aged between 18-35 years and diagnosed with PCOS who were seeking conception and presented at the outpatient’s infertility clinic of our department were eligible for initial evaluation. Eligibility criteria included a confirmed diagnosis of PCOS according to Rotterdam criteria [16], ovulation resistance to letrozole (no dominant follicles [>17mm] on mid cycle transvaginal ultrasound after a maximum letrozole dosing of 7.5 mg /day for 5 cycle days starting from cycle day 2) [17], a Body Mass Index (BMI) less than or equal 30 kg/m2, and a normal Hysterosalpingography (HSG) and/or diagnostic laparoscopy. Women aged between 18-35 years and diagnosed with PCOS who were seeking conception and presented at the outpatient’s infertility clinic of our department were eligible for initial evaluation. Eligibility criteria included a confirmed diagnosis of PCOS according to Rotterdam criteria [16], ovulation resistance to letrozole (no dominant follicles [>17mm] on mid cycle transvaginal ultrasound after a maximum letrozole dosing of 7.5 mg /day for 5 cycle days starting from cycle day 2) [17], a Body Mass Index (BMI) less than or equal 30 kg/m2, and a normal Hysterosalpingography (HSG) and/or diagnostic laparoscopy.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 10/09/2025 PACTR Admin Reasons for exclusion include women with endocrine disorders (e.g., active thyroid disease, adult-onset adrenal hyperplasia, diabetes, hyperprolactinemia, or adrenal-related hyperandrogenism), those concurrently using insulin-sensitizing medications like metformin, individuals with contraindications to pregnancy, and those with conditions that preclude inositol use, such as chronic liver or kidney disease. Reasons for exclusion include women with endocrine disorders (e.g., active thyroid disease, adult-onset adrenal hyperplasia, diabetes, hyperprolactinemia, or adrenal-related hyperandrogenism), those concurrently using insulin-sensitizing medications like metformin, individuals with contraindications to pregnancy, and those with conditions that preclude inositol use, such as chronic liver or kidney disease.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/09/2025 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/09/2025 Self Funded None, None, None, , Egypt, Self Funded, The principle investigator Ahmed Soliman, 6 Al-Ashkar St., Mansoura, Mansoura, 35511, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/09/2025 Self Funded by the principle investigator The principle investigator Ahmed Soliman, 6 Al-Ashkar St., Mansoura, Mansoura, 35511, Egypt, Self Funded, Ahmed Soliman, 6 Al-Ashkar St., Mansoura, Mansoura, 35511, Egypt, Self Funded,