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.: PACTR202202641392530 Date of Approval: 16/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the efficacy of oral Dydrogesterone with Micronized vaginal Progesterone for luteal phase support in women undergoing In vitro fertilization at the Federal Medical Centre Abuja: a randomized clinical trial
Official scientific title Comparison of the efficacy of oral Dydrogesterone with Micronized vaginal progesterone for luteal phase support in women undergoing In vitro fertilization (IVF) at the Federal Medical Centre Abuja: a randomized clinical trial
Brief summary describing the background and objectives of the trial Background: In vitro fertilization has revolutionized the management of Infertility worldwide. After embryo transfer, luteal phase support is believed to play a key role in enhancing treatment outcomes. Progesterone, the usual drug of choice for luteal support, may be administered via various routes including: oral, vaginal and intramuscular routes. In spite of considerable evidence from developed countries, showing no difference in clinical outcome, IVF practice in Nigeria appears skewed in favor of the use of micronized vaginal progesterone pessaries instead of oral Dydrogesterone. There is a dearth of studies in Nigeria comparing the efficacy of micronized vaginal progesterone with oral Dydrogesterone in patients undergoing IVF treatment. Objective: To compare the efficacy of oral Dydrogesterone with micronized vaginal progesterone for luteal phase support in women undergoing In vitro fertilization at the Federal Medical Centre, Abuja, Nigeria. Methods: This shall be a single centre, randomized controlled trial at the Fertility centre of the Federal Medical Centre, Abuja Nigeria. A total of 300 eligible and consenting participants shall be recruited over a duration of one year. They shall be assigned to receive a daily dose of either 800mg of micronized vaginal progesterone (Cyclogest®, LD Collins & Co, UK) or 30mg of oral Dydrogesterone (Duphastone®, Abbott.,Olst, Netherlands) beginning from the day of follicle aspiration until pregnancy test is conducted 14 days after blastocyst embryo transfer. Following a positive pregnancy test, the either of these medications shall be continued until 12 weeks of gestation. The outcome measures will be assessed in terms of clinical pregnancy rates, miscarriage rates and on-going pregnancy rates.
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 01/01/2022
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Dydrogesterone 10mg thrice daily The drug shall be given from oocyte retrieval until pregnancy test, and thereafter, extended to 12 weeks if pregnancy test is positive Eligible and consenting study participants shall receive 30mg total daily dose of oral Dydrogesterone (Duphaston®, Abott, Oslt, Netherland) in 3 divided doses starting from the day of oocyte retrieval and shall continue until pregnancy test is carried out 14 days after. If the pregnancy test is positive, the drug shall be continued until 12 weeks of gestation 150
Control Group Micronized vaginal progesterone 400 milligram vaginal pessaries inserted twice daily The drug shall be given from the day of oocyte retrieval until the day of pregnancy test, and continued to 12 weeks of gestation if the pregnancy test is positive. Eligible and consenting participants shall be given a total dose of 800milligram of Micronized vaginal progesterone (Cyclogest®, LD Collins & Co, UK) to be inserted twice daily into the vagina from the day of oocyte retrieval and continued until pregnancy test 14 days after. If the pregnancy test is positive, the drug shall be continued until 12 weeks of gestation. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Signed informed consent Premenopausal females, age ≥ 19 years ≤ 44 years Non-smokers Normal follicular phase (Day 2-4) hormones (FSH, LH, E2, PRL, T, and TSH Documented history of infertility Normal endovaginal ultrasound at screening Subject is not pregnant Clinically indicated protocol for induction of IVF with a fresh embryo Single or dual embryo transfer BMI ≥ 18 and ≤ 30 kg/m2 Evidence of diseases which could limit participation in or completion of the study Acute urogenital disease Known allergic reactions to progestogens Intake of any other experimental drug or on going treatment of any illness participation in any other clinical trial within 30 days prior to study start Disability or any condition leading to lack of fitness to participate in or to complete the study Current or recent substance abuse, including alcohol and tobacco History of chemotherapy or radiotherapy Patients with more than 3 unsuccessful IVF attempts Women in whom pregnancy is contraindicated Refusal or inability to comply with the requirements of the study protocol for any reason History of recurrent pregnancy loss Adult: 19 Year-44 Year 19 Year(s) 44 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 08/02/2022 Health Research Ethics committee Federal Medical centre Abuja
Ethics Committee Address
Street address City Postal code Country
Plot 95, Research and Institutions district, beside EFCC Headquarters/ NOUN, Abuja Abuja 900108 Nigeria
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 08/02/2022 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre Abuja Abuja 900108 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by endovaginal ultrasound scan 12 weeks of gestation
Secondary Outcome Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer Day 14 after embryo transfer
Secondary Outcome Percentage of Participants With Presence of Fetal Heart Beats at 8 Week's Gestation Determined by endovaginal Ultrasound 6 weeks after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fertility unit of Federal Medical Centre Abuja Nigeria plot 95, Research/ Institutions district, beside EFCC Headquarters /NOUN, Abuja Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Researcher plot 95, Research and Institutions district, beside EFCCHeadquarters/NOUN Abuja 900108 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benedict Ekaidem drbenekaidem@yahoo.com +2348038803534 Department of Obstetrics/Gynecology Federal Medical Centre, Abuja
City Postal code Country Position/Affiliation
Abuja Nigeria Consultant and Head of Obstetrics Gynecology
Role Name Email Phone Street address
Public Enquiries Elizabeth IshoriboKiva ishoriboelizabeth96@gmail.com +2348034280304 Department of Obstetrics/ Gynecology, Federal Medical Centre, Abuja
City Postal code Country Position/Affiliation
Abuja Nigeria Chief Resident
Role Name Email Phone Street address
Scientific Enquiries Benedict Ekaidem drbenekaidem@yahoo.com +2348038803534 Department of Obstetrics/Gynecology, Federal Medical Centre, Abuja
City Postal code Country Position/Affiliation
Abuja Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in Infertility, In vitro fertilization and luteal phase support. Statistical Analysis Plan,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 Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval.
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