UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004513
Receipt number 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 22:21:38

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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

Obstetrics 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 or person

Institute

Faculty of Medicine, Mansoura University Hospitals, Mansoura, Egypt

Institute

Department

Personal name



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

Value
https://center6.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