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.: PACTR201510001265121 Date of Approval: 13/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title phyto estrogen to improve pregnancy rates during ovulation induction by clomiphene citrate in women with polycystic ovarian syndrome
Official scientific title Peri ovulatory phyto estrogen to improve pregnancy rates during ovulation induction by clomiphene citrate in women with polycystic ovarian syndrome
Brief summary describing the background and objectives of the trial The effect of follicular phase oral phyto-estrogen, cimicifuga racimosa extract (klimadynon®, Bionorica, neumarket i.d OBf., Germany), in patients with poly-cystic ovary syndrome managed by clomiphene citrate induction and timed intercourse , It has been suggested that oral phyto-estrogen can oppose antiestrogen effects of clomiphene citrate on cervical mucous and endomertrium so it can improve pregnancy rate during ovulation induction in women with polycystic ovarian syndrome .benefits of phyto-estrogen were observed without any reduction in effect of clomiphene citrate to induce ovulation.all participants after informed consent allocated two groups .patients will be assigned two groups by closed envelope computerized method. The study will be conducted according to guidelines as stated in Minia University protocol after being approved by the Institutional Review Board of Maternity Hospital. It will include 70 patients who will be randomized at the beginning of treatment cycle by sealed opaque envelopes containing random generated numbers. Patients with PCOS will recruited in the study from attendees of OPD of Minia university maternity hospital, Egypt . group (1)35 patients will receive clomiphene citrate 50mg daily for 5days starting on the 2nd day of the menstrual cycle. group (2)35 patients will receive both clomiphene with the same regimen in the control group plus 20mg cimicifuga racimosa extract (klimadynon®) starting on 7th day of the cycle till day of HCG injection. Endometrial thickness and follicular growth will assessed by transvaginal US. When follicles reached 18 mm , 10,000 IU human chorionic Gonadotropin will administered to induce ovulation. Both groups will compared as regard Primary Outcome Measures: Pregnancy rate Secondary outcome measures : Hormonal changes ( 21st day progesrone FSH ,LH , estradiol)in the study and control group,day of HCG injection endometrial thickness ,number of follicles > 17mm at time of HCG injection .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied poly cystic ovary syndrome,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 01/12/2016
Actual Last follow-up date 12/08/2017
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 70
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
mail.mu.edu.eg Minia University
mail.mu.edu.eg Minia University
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised sealed opaque envelopes containing random generated numbers simple randomization using closed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group clomiphene treatment 50mg twice 5 days clomiphene given in the second day of the cycle twice daily for 5day 225 Historical
Experimental Group phytoestrogen treatment 20mg 3-10 days patient given clomiphene citrate with same dose as control group plus phytoestrogen started on 7th day of cycle 20mg twice daily till the time of HCG injection 225
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Informed consent. All infertile women less than 35 year with single factor infertility diagnosed as PCOS had received neither clomiphene citrate nor laparoscopic ovarian drilling . patients has multiple factors causing infertility . previous ovarian drilling previous induction with clomiphene citrate or HMG . age more than 35years 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
Yes 23/08/2015 Minia University Institutional Review Board of Maternity Hospital.
Ethics Committee Address
Street address City Postal code Country
Minia 5161 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rate pregnancy rate at treatment cycle cumulative pregnancy rate after 3 cycles
Secondary Outcome Hormonal changes ( 21st day progesrone ,FSH,LH,estadiol)endometrial thickness in study and control group day of HCG injection , number of follicles more than 17mm at tiime of HCG injection treatment cycle post treatment follow up over 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University PO Box 61519 Minia 5161 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia University PO Box 61519 Minia 5161 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Minia Maternity Hospital PO Box 61519 Minia 2151 Egypt Hospital
Primary Sponsor Minia University PO Box 61519 Minia 5161 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Taha Hussin Minia 5161 Egypt
Mahmoud Hosni Taha Hussin Minia 5161 Egypt
Ahmad Mahran Shalabi Minia 5161 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Elkateeb rehamelkhateeb78@yahoo.com 0020101196648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 5161 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Mahmoud Hosni hosnimahmoud@yahoo.com 00201000670107 Taha Hussin
City Postal code Country Position/Affiliation
Minia 5161 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahran ezzeldin_ahmad@yahoo.com 00201115551073 Shalabi
City Postal code Country Position/Affiliation
Minia 5161 Egypt lecturer
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
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