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.: PACTR202202892502375 Date of Approval: 01/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gonadotropins- letrozole, gonadotropin- clomiphene citrate, and gonadotropins only for controlled ovarian super stimulation in women with polycystic ovary syndrome undergoing intracytoplasmic sperm injection.
Official scientific title Gonadotropins- letrozole, gonadotropin- clomiphene citrate, and gonadotropins only for controlled ovarian super stimulation in women with polycystic ovary syndrome undergoing intracytoplasmic sperm injection.
Brief summary describing the background and objectives of the trial More than 70 million couples suffer from infertility with about 37% of cases are caused by female factor infertility. Polycystic ovary syndrome (PCOS) -a common endocrine disorder- is the most common cause of female infertility. Ovulation induction is the main treatment for infertile women using clomiphene citrate (CC), aromatase inhibitors (AI), or gonadotropins. Laparoscopic ovarian drilling was introduced as a management option with comparable effects to gonadotropins. Intracytoplasmic sperm injection (ICSI) is a widely practiced procedure and commonly reserved for PCOS patients who failed to respond to the initial lines of ovulation induction or have multiple causes of infertility. However; they are at increased risk of ovarian hyperstimulation syndrome (OHSS). Increased interest has been directed towards the use of oral ovulation induction agents combined with gonadotropins to decrease its dose and accordingly the rate of OHSS and cycle cancellation. Increased doses of CC have been associated with increased ovulation rates without concomitant increase in pregnancy rates. Aromatase inhibitors are associated with increased endometrial receptivity and were associated with improved ICSI outcomes in normal responders. This study was conducted to compare the effect of combined aromatase inhibitors and gonadotropins, CC and gonadotropins, and gonadotropins only in women undergoing ICSI.
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 Prevention
Anticipated trial start date 01/10/2018
Actual trial start date
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group gonadotropin only HMG (Merional©, IBSA, Egypt) starting dose 75-225 IU adjusted according to patient response from Day 2 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo tablets were administered from day 3- 7. until growth of follicles HMG (Merional©, IBSA, Egypt) starting dose 75-225 IU adjusted according to patient response from Day 2 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo tablets were administered from day 3- 7. 50 Active-Treatment of Control Group
Experimental Group clomiphene citrate group clomiphene citrate (Clomid©, Global Napi pharmaceuticals, Cairo, Egypt) 5 mg daily from Day 3 to Day 7 along with HMG (Merional©, IBSA, Egypt) starting dose 75 IU adjusted according to patient response from Day 7 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo was administered till the time of HMG administration. until follicle maturation clomiphene citrate (Clomid©, Global Napi pharmaceuticals, Cairo, Egypt) 5 mg daily from Day 3 to Day 7 along with HMG (Merional©, IBSA, Egypt) starting dose 75 IU adjusted according to patient response from Day 7 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo was administered till the time of HMG administration. 50
Experimental Group aromatase inhibitor group Letrozole (Femara©, Novartis pharmaceuticals, Cairo, Egypt) 5 mg daily from Day 3 to Day 7 along with HMG (Merional©, IBSA, Egypt) starting dose 75 IU adjusted according to patient response from Day 7 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo was administered till the time of HMG administration. until follicle maturation Letrozole (Femara©, Novartis pharmaceuticals, Cairo, Egypt) 5 mg daily from Day 3 to Day 7 along with HMG (Merional©, IBSA, Egypt) starting dose 75 IU adjusted according to patient response from Day 7 onward till trigger by HCG (Choriomon© 5000 units, IBSA, Egypt). Placebo was administered till the time of HMG administration. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) women aged 20- 40 years, b) body mass index (BMI) 20- 35, c) first trial for ICSI, d) presenting with primary infertility, e) euthyroid, and f) normal serum prolactin. a) previous pelvic surgery, b) chronic illnesses, and c) women refusing to participate in the study. Adult: 19 Year-44 Year 19 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 19/09/2018 research ethics committee
Ethics Committee Address
Street address City Postal code Country
4.5 kilo ring road ismailia, egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome successful results regarding number of mature follicles, number of embryos resulted, pregnancy rates and liv birth rates within the ICSI cycle
Secondary Outcome side effects of each regimen and its cost within the ICSI cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elazhar university eldarasa cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed mamdouh 4.5 ring road ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed mamdouh ring road kilo 4.5 ismailia Egypt
mariam lotfy ring road kilo 4.5 ismailia Egypt
amal elshahat ring road kilo 4.5 ismailia Egypt
gamal aboelsorour ring road kilo 4.5 ismailia Egypt
omima tharwat ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed mamdouh mmamdouh@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries omima tharwat omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries omima tharwat omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing is possible when needed and after approval of the research ethics committee Study Protocol after completion of the study after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/01/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/01/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information