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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909615909874 Date of Registration: 30/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the Effect of Transvaginal Ovarian Needle Puncture on Women with Polycystic Ovary Syndrome
Official scientific title Evaluation of the Effect of Transvaginal Ovarian Needle Puncture on Women with Polycystic Ovary Syndrome
Brief summary describing the background and objectives of the trial polycystic ovary syndrome is a major cause of female infertility. in clomiphene resistant women, different treatment modalities are available. the introduction of cold drilling would be of help especially in low resource countries. This study aims to evaluate the effectiveness of Ultrasound-guided transvaginal ovarian needle puncture on improving outcome of management in women with polycystic ovary syndrome.
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: Other
Anticipated trial start date 30/06/2017
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group letrozole group letrozole 2.5mg twice daily starting from the 2nd day of the menstrual cycle for 5 days single cycle evaluation letrozole group 27 Active-Treatment of Control Group
Experimental Group cold drilling and letrozole group women will undergo Ultrasound-Guided Transvaginal Needle Ovarian puncture prior to induction of ovulation by the same protocol used in group A in the next cycle single cycle cold drilling and letrozole 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Women in reproductive age (18-45 years ) 2) All participants fulfilled the diagnosis for PCOS, two of the following three criteria: A) Chronic anovulation. B) Hyperandrogenism (clinical/biologic). C) Polycystic ovaries on transvaginal ultrasound scan , ovarian enlargement and at least one ovary with 10–30 subcapsular follicles of 3–8 mm in diameter were present in each case. 3) All patients are clomiphene citrate resistant; means that women were previously treated with clomiphene citrate 100mg daily for 5 days per cycle, for 2–3 cycles, with persistent anovulation or ovulation with very thin endometrium, <5 mm at the time of HCG adminstiration. 4) All patients have normal TSH and prolactin level 1. Previous history of ovarian drilling 2. previous treatment with metformin 3. patients with an abnormal hysterosalpingogram 4. previous pelvic operations 5. preexisting ovarian cyst on day three of the cycle 6. patient with husband has abnormal semen parameters Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 45 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 06/06/2017 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the effect of Ultrasound-guided transvaginal ovarian needle puncture on polycystic ovary syndrome women who are resistant to clomiphene citrate. single cycle
Secondary Outcome To assess Ultrasound-guided transvaginal ovarian needle puncture effect on the on hormonal profile, ovulation rates and the improvement of symptoms on polycystic ovary syndrome women. single cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Momen Mahmoud Elsayed ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Momen Mahmoud ElSayed ring road kilo 4.5 ismailia Egypt
Mohamed Mouselhy Farrag ring road kilo 4.5 ismailia Egypt
khaled Ahmed Atwa ring road kilo 4.5 ismailia Egypt
Mohamed ElPrince Adel ring road kilo 4.5 ismailia Egypt
omima tharwat taha ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Momen elsayed mo2mengomaa@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing of the data will be through the provided results in the published manuscript and after approval of our research ethics committee Study Protocol when accepted for publication after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Our study included 54 Participants with clomiphene resistant PCOS women with primary or secondary infertility. The sample was divided randomly into two groups each containing 27 participants, the Control group included 27 patients received aromatase inhibitors (letrozole 2.5mg twice daily twice daily starting from 2nd day of menstrual cycle for 5 days) and FSH administered with 75 IU daily from cycle day 3 and maintained for up to 14 th of th cycle. The study group included 27 patients underwent Ultrasound-Guided Trans-vaginal Needle Ovarian puncture prior to induction of ovulation by the same previous protocol.there is no statistically significant difference between the two groups regarding LH, FSH and Testosterone levels. The LH/FSH ration in both groups is high with no statistically significant difference at 95% level of confidence.There is a marked decline in LH level in study group which was treated by trans-vaginal ovarian puncture than the control group which was reflected on LH/FSH ration which is markedly decline in the study group, Also Free testosterone showed decline in the study group. All results are statistically significant at 95% level of confidence. 03/09/2019 31/03/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/ruasarku5azt509/protocol.docx?dl=0
Changes to trial information