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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: www.pactr.org

Trial no.: PACTR201101000269346 Date registered: 2010/12/20
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
Purpose of the trial Treatment
Anticipated trial start date 2011-03-01
Actual trial start date
Anticipated date of last follow up 2012-09-01
Actual date of last follow up
Anticipated target sample size (number of participants) 600   
Actual target sample size (number of participants) not yet   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Single group: all participants receive same intervention throughout study Randomised simple randomization using coin-tossing sealed opaque envelopes Masking/blinding used

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 Min age Max age Gender
consenting women women with unexplained infertility known male factor infertility known factor as a cause of infertility 18 Years 35 Years 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 2011/02/28 NAUTHEC
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Ethical Committee 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 NAUTHEC
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Ethical Committee (NAUTHEC); 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
LIFE SPECIALIST HOSPITAL IKEMBA DRIVE NNEWI PMB 5025 Nigeria
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL(NAUTH) NNEWI ONITSHA ROAD 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 Fax
Principal Investigator Dr ELEJE GEORGE UCHENNA georgel21@yahoo.com +2348068117444
Street address City Postal code Country Position / Affiliation
NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria SENIOR REGISTRAR
Role Name Email Phone Fax
Scientific Enquiries Prof JI IKECHEBELU jikechebelu@yahoo.com 2348034044189
Street address City Postal code Country Position / Affiliation
DEPARTMENT OF O & G NAUTH NNEWI Nigeria consultant obstetrician-gynaecologist
Role Name Email Phone Fax
Public Enquiries Mr Daniel UGWUANYI danwaves2000@yahoo.com 2348033971062
Street address City Postal code Country Position / Affiliation
VINE HOUSE LTD Nigeria Director Lecturer