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.: PACTR201101000269346 Date of Approval: 20/12/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PROGESTERONE USE IN UNEXPLAINED INFERTILITY
Official scientific title THE EFFECTIVENESS OF PROGESTERONE IN INCREASING THE FECUNDABILITY AMONG WOMEN WITH ANOVULATORY AND UNEXPLAINED INFERTILITY:A RANDOMIZED CONTROL TRIAL
Brief summary describing the background and objectives of the trial Infertility is a common gynaecological complaints.It is often more worrisome when it is unexplained. There have been some anecdotal reports on the usefulness of progesterone in women with infertility. There is therefore need to subject these findings to randomized control trial. This study aims to determine the effectiveness of progesterone and its agents in increasing the fecundability rate among women with unexplained infertility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2011
Actual trial start date
Anticipated date of last follow up 01/09/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
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
Randomised simple randomization using coin-tossing Sealed opaque envelopes Masking/blinding used
Randomised simple randomization using coin-tossing Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo one ampule 25 mg once placebo intramuscularly on the first day of menses and timed intercourse during intervention cycle 300 Placebo
Experimental Group PROGESTERONE GROUP one ampoule 25mg once progesterone intramuscularly once on the 1st day of menses and timed intercourse during intervention cycle. If no pregnancy, 2 treatment cycles administered 300
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consenting women women with unexplained infertility known male factor infertility known factor as a cause of infertility 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
No NAUTHEC
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Ethical Committee (NAUTHEC); NNEWI PMB 5025 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
No 28/02/2011 NAUTHEC
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Ethical Committee NNEWI PMB 5025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome positive pregnancy test within 3 months of intervention
Primary Outcome breast tenderness within one week of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL(NAUTH) NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
LIFE SPECIALIST HOSPITAL IKEMBA DRIVE NNEWI PMB 5025 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
LIFE SPECIALIST HOSPITAL, LTD IKEMBA DRIVE NNEWI PMB 5025 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LIFE SPECIALIST HOSPITAL, LTD IKEMBA DRIVE NNEWI Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof JI Ikechebelu IKEMBA DRIVE NNEWI PMB 5025 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ELEJE GEORGE UCHENNA georgel21@yahoo.com +2348068117444 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI PMB 5025 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries Daniel UGWUANYI danwaves2000@yahoo.com 2348033971062 VINE HOUSE LTD
City Postal code Country Position/Affiliation
Nigeria Director Lecturer
Role Name Email Phone Street address
Scientific Enquiries JI IKECHEBELU jikechebelu@yahoo.com 2348034044189 DEPARTMENT OF O & G
City Postal code Country Position/Affiliation
NAUTH NNEWI Nigeria consultant obstetrician-gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information