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.: PACTR202310849449401 Date of Approval: 12/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of Sildenafil Citrate in the Management of Unexplained Infertility in Kisangani, Democratic Republic of Congo
Official scientific title Clomiphene citrate and Sildenafil citrate versus Clomiphene citrate and Estradiol valerate for Induction of ovulation in congolese patient with unexpalined infertility: A Randomised Controlled Trial.
Brief summary describing the background and objectives of the trial Traditionally, the diagnosis of unexplained infertility is made when the standard aetiological work-up has failed to reveal any abnormality. For this reason, treatment is typically empirical. first line treatment of unexplained infertility includes observation of the expectant state with timed intercourse and life changes, or clomiphene citrate and intra uterine insemination. In Africa, the most infertile couples do not accept to observe the expectant state. This study aims to evaluate the effectiveness and the safety of Clomiphene citrate + Sildenafil citrate compared with Clomiphene citrate + Estradiol valerate in inducing ovulation in congolese patients suffering from unexplained infertility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CSEK
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 01/07/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 01/07/2023
Actual Last follow-up date 31/10/2023
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
UNIKIS/CER/08/2021
UNIKIS.CER.08.2021 Research Ethics committee of the University of Kisangani
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sildenafil citrate 25mg tab orally twice daily 5 days each cycle (from day 8 to day 12 of menstrual cycle) for a maximum of 3 cycles Patient in experiemental group received received Clomiphene Citrate 50mg tab orally twice daily from day 3 to day 7 of menstrual cycle of the patient, then Sildenafil citrate 25mg tab orally twice daily from day 8 of the same cycle till day 12. Patients were clinically and sonographically monitored. Follicle monitoring was performed every 24 to 48 hours depending on follicular growth. When at least one follicle reached 18mm in diameter, endometrium thickness and echogenicity were determined, as well as uterine artery velocity. Then, ovulation was triggered with Pregnyl 5000 IU intra muscular. Sexual intercourse was timed 34-36 hours after ovulation has been triggered. 14 days after triggering ovulation, urine ß-HCG test was performed. Patient with positif test underwent transvaginal sonography to confirm pregnancy, those with negative test resumed the treatment following the same protocole as in the previous cycle, for a maximum of three cycles. 72
Control Group Estradiol valerate 2mg tab orally twice daily 5 days each cycle (from day 8 to day 12 of menstrual cycle) for a maximum of 3 cycles Patients in the control groupe received Clomiphene Citrate 50mg tab orally twice daily from day 3 to day 7 of menstrual cycle of the patient, then Estradiol valerate 2mg orally twice daily from day 8 of the same cycle till day 12. Patients were clinically and sonographically monitored. Follicle monitoring was performed every 24 to 48 hours depending on follicular growth. When at least one follicle reached 18mm in diameter, endometrium thickness and echogenicity were determined, as well as uterine artery velocity. Then, ovulation was triggered with Pregnyl 5000 IU intra muscular. Sexual intercourse was timed 34-36 hours after ovulation has been triggered. 14 days after ovulation trigger, urine ß-HCG test was performed. Patient with positif test underwent transvaginal sonography to confirm pregnancy, those with negative test resumed the treatment following the same protocole as in the previous cycle, for a maximum of three cycles. 72 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged 19-34, whose infertility tests were normal then diagnosed as unexplained infertility. Informed (written) consent to participate in the study. Any cause of infertility (male factors, tubal or ovarian factors, or any other factors) Chronic illness as cardiac or renal disease Any contraindication for used drugs Refusal to participate in the study. Adult: 19 Year-44 Year 19 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 20/06/2021 University of Kisangani Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Avenue Munyororo Kisangani 2012 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Conception rate (clinical pregnancy) 6 months after the beginning treatment
Secondary Outcome Thickness and echogenicity of the endometrium Velocity of uterine blood flow (pulsatility index and resistance index) Number of mature follicles Ovulation rate Each cycle, on the day ovulation is triggered, and 3-7 days after ovulation is triggered.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Clinics of Kisangani Avenue Munyororo Kisangani 2012 Democratic Republic of the Congo
Kisangani Angels Clinic Munyororo Kisangani Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Kisangani Avenue Munyororo Kisangani 2012 Democratic Republic of the Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor FONDATION DES ANGES Av du livre/Huillerie Kinshasa Democratic Republic of the Congo Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Modia Oyandjo Antoine 2eme Av Brazza Kisangani Democratic Republic of the Congo
Juakali Sihalikyolo Jeannot Av du Los Angeles Kisangani Democratic Republic of the Congo
Marini Djangeinga Roland Avenue Hippocrate Liege 4000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bosenge Nguma jdbosenge86@gmail.com +243811964061 Avenue de Trois Maisons
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo University of Kisangani. Faculty of Medicine and Pharmacy
Role Name Email Phone Street address
Public Enquiries Labama Otuli nlabama@gmail.com +243813229686 Avenue du Bassin
City Postal code Country Position/Affiliation
Kisangani 2012 Democratic Republic of the Congo Faculty of Medicine and Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Katenga Bosunga katengabosunga@gmail.com +243823551472 Avenue de Trois Maisons
City Postal code Country Position/Affiliation
Kisangani 2012 Democratic Republic of the Congo Faculty of Medicine and Pharmacy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We undertake to share the individual participant data that underlie the results that will be reported in this study, after deidentification. Data will be shared to researchers who will provide a methodologically sound proposal. Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 3 years following article publication Proposal should be directed to jdidier.bosenge@unikis.ac.cd. To gain access, data requestors will need to sign a data access agreement.
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