UMIN-CTR Clinical Trial

Basic information
Public title	Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome.
Acronym	Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome
Scientific Title	Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome.
Scientific Title:Acronym	Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome
Region	Africa

Condition
Condition	recruiting
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the efficacy of orlistat in overweight and obese PCO patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	clinical pregnancy rate
Key secondary outcomes	weight reduction

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	receive clomiphene citrate for 6 months 5 days at the start of menstruation plus orlista 3 times/day for 6 months or stopped when patient get pregnant
Interventions/Control_2	receive clomiphene citrate only for 5 days / month for 6 months only
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	18 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	PCO patients diagnosed by revised Rotterdam's criteria 2003 age 18-35years BMI >25 and <35 no recent history of drug intake or deitary modifications
Key exclusion criteria	Male factor all other causes of infertility untreated hypothyriodism hyperprolactinemia renal or hepatic impairment malabsorption syndrome
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ayman Middle name Shehata Last name Dawood
Organization	Tanta University
Division name	Eman Heikal
Zip code	31111
Address	Tanta university
TEL	+201020972067
Email	ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person	1st name Ayman Middle name Shehata Last name Dawood
Organization	Tanta university
Division name	Eman Heikal
Zip code	31111
Address	Tanta university
TEL	+201020972067
Homepage URL
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta university Obstetrics and Gynecology department
Institute
Department

Funding Source
Organization	Tanta University Obstetrics and gynecology department
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	Tanta University
Address	Elgeish st., Tanta, Egypt
Tel	+201020972067
Email	ayman.dawood@med.tanta.edu.eg

Secondary IDs
Secondary IDs	YES
Study ID_1	Eman Heikal
Org. issuing International ID_1	Tanta University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 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	60
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	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 08 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033248