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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028231
Receipt No. R000032313
Scientific Title Ultrasound guided aspiration of endometrioma before ultra-long agonist protocol in icsi patients: Tanta University experience.
Date of disclosure of the study information 2018/06/01
Last modified on 2021/07/29

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Basic information
Public title Ultrasound guided aspiration of endometrioma before ultra-long agonist protocol in icsi patients: Tanta University experience.
Acronym Ultrasound guided aspiration of endometrioma before ultra-long agonist protocol in icsi patients: Tanta University experience.
Scientific Title Ultrasound guided aspiration of endometrioma before ultra-long agonist protocol in icsi patients: Tanta University experience.
Scientific Title:Acronym Ultrasound guided aspiration of endometrioma before ultra-long agonist protocol in icsi patients: Tanta University experience.
Region
Africa

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

Objectives
Narrative objectives1 To evaluate the value of endometrioma aspiration before pituitary down regulationon on ICSI results
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical pregnancy rate
Key secondary outcomes dose of gonadotropins, recurrence of endometrioma or pelvic infections,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Ultrasounnd endometrioma aspiration before ultra-long down regulation of pituitary.
Interventions/Control_2 No aspiration of endometrioma
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
35 years-old >=
Gender Female
Key inclusion criteria age 20-35 years
endometrioma 3-5cm
Unilateral endometrioma
Recurrent endometriomas after surgery,
Normal BMI (18.5-24.9)
Key exclusion criteria Previous aspiration
Poor ovarian reserve (AMH <0.8)
Previous ovarian surgery,
previous oophorectomy of one ovary
Uterine factors (adenomyosis, myoma or other anomaly of uterus),
Male factors,
Refusal to participate in the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Ayman
Middle name Shehata
Last name Dawood
Organization Tanta university
Division name Ayma shehata dawood
Zip code 31111
Address Tanta, gharbia, Egypt
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 Ayman shehata dawood
Zip code 31111
Address Tanta, gharbia, Egypt
TEL +201020972067
Homepage URL
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta University, Faculty of medicine
Department of Obstetrics and gynecology
Institute
Department

Funding Source
Organization Tanta University
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 Tanta, gharbia, Egypt
Tel +201020972067
Email ayman.dawood@med.tanta.edu.eg

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
2018 Year 06 Month 01 Day

Related information
URL releasing protocol gi-bin/ctr_e/ctr_up_reg_f5.cgi
Publication of results Unpublished

Result
URL related to results and publications gi-bin/ctr_e/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled 90
Results will be done after publication
Results date posted
2021 Year 07 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics This study enrolled 90 infertile patients from the two universities. Enrolled patients were assessed for eligibility according to inclusion and exclusion criteria. The eligible patients (n= 84) were allocated equally in both groups with 42 patients in each group. The final analyzed patients in each group were 41 in group I and 40 in group II.
Participant flow The flow chart is presented in figure 3.
Adverse events none
Outcome measures Primary outcome was the clinical pregnancy rates. The secondary outcomes were dose of gonadotropins, recurrence of endometrioma or pelvic infections.
Plan to share IPD
IPD sharing Plan description 3 months after publication on valuable request

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 07 Month 01 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 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 07 Month 14 Day
Last modified on
2021 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032313

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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