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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004513
Receipt No. R000005395
Scientific Title Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome. A randomized controlled trial
Date of disclosure of the study information 2010/11/06
Last modified on 2010/11/06

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Basic information
Public title Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome. A randomized controlled trial
Acronym Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome.
Scientific Title Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome. A randomized controlled trial
Scientific Title:Acronym Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome.
Region
Africa

Condition
Condition Polycystic ovary syndrome
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of laparoscopic ovarian diathermy vs. continuation of clomiphene citrate for up to six further cycles in polycystic ovary syndrome patients who failed to achieve pregnancy despite previous successful clomiphene induced ovulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical pregnancy rate
Key secondary outcomes Midcycle endometrial thickness, the miscarriage and live birth rates

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Laparoscopic ovarian diathermy
Interventions/Control_2 Clomiphene citrate for up to six cycles
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 1) Polycystic ovary syndrome who failed to achieve pregnancy despite previous successful clomiphene induced ovulation for six cycles.
2)Patent Fallopian tubes proved by hysterosalpingography
3)Normal semen analysis for their partners
4)Normal serum prolactin, thyroid stimulating hormone and 17 hydroxyprogesterone
Key exclusion criteria 1)Other causes of infertility
2)Age over 40 years
3)Contraindication to general anaesthetic
4)women with a previous pregnancy
Target sample size 172

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatem Abu Hashim
Organization Faculty of Medicine, Mansoura University, Mansoura, Egypt
Division name Department of Obstetrics and Gynecology
Zip code
Address El-Gomhoria street, Mansoura, Egypt
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Faculty of Medicine, Mansoura University Hospitals
Division name Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
Email mansobgyn@yahoo.com

Sponsor
Institute Faculty of Medicine, Mansoura University Hospitals, Mansoura, Egypt
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 06 Day
Last modified on
2010 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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