UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028231 |
|---|---|
| Receipt number | R000032313 |
| Scientific Title | Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol in intra-cytoplasmic sperm injection cycles: A multicenter randomized clinical trial |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/12/02 00:44:51 |
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Basic information
Public title
Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol in intra-cytoplasmic sperm injection cycles: A multicenter randomized clinical trial
Acronym
Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol in intra-cytoplasmic sperm injection cycles: A multicenter randomized clinical trial
Scientific Title
Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol in intra-cytoplasmic sperm injection cycles: A multicenter randomized clinical trial
Scientific Title:Acronym
Outcomes of ovarian endometrioma aspiration before ultra-long agonist protocol in intra-cytoplasmic sperm injection cycles: A multicenter randomized clinical trial
Region
| Africa |
Condition
Condition
completed
Classification by specialty
| Obstetrics 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
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
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University, Faculty of medicine
Department of Obstetrics and gynecology
Institute
Department
Personal name
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
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
| 2022 | 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
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032313
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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