UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032841 |
|---|---|
| Receipt number | R000037453 |
| Scientific Title | Booster HCG dose for unruptured follicles in normally stimulated cycles |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2022/12/05 00:54:48 |
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Basic information
Public title
Booster HCG dose for unruptured follicles in normally stimulated cycles
Acronym
Booster HCG for unruptured follicles
Scientific Title
Booster HCG dose for unruptured follicles in normally stimulated cycles
Scientific Title:Acronym
Booster HCG for unruptured follicles
Region
| Africa |
Condition
Condition
Nor recruiting
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pregnancy rate after booster dose HCG in unruptured follicles
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pregnancy rates
Key secondary outcomes
OHSS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
HCG booster dose (10,000IU)given IM for patients with unruptured MGF after 48 hours follow up of the previous dose.
Interventions/Control_2
Placebo saline 2 ml given IM for patients with unruptured MGF after 48 hours follow up of the previous dose.
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
Patient suffering infertility whether primary or secondary with unruptured MGf after giving the ususal 10,000IU IM at the time of ovulation
Normally stimulated cycles
Normal other factors of infertility
Key exclusion criteria
Other factors of infertility
IVF/ICSI cycles
Poor ovarian reserve
Target sample size
80
Research contact person
Name of lead principal investigator
| 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
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
Obstetrics and Gynecology department
Institute
Department
Personal name
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
Tanta, gharbia, Egypt
Tel
+201020972067
ayman.dawood@med.tanta.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Adel Elgergawy
Org. issuing International ID_1
Tanta University
Study ID_2
Ahmed Elhalwagy
Org. issuing International ID_2
Tanta University
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
We still analyzing results
Publication of results
Unpublished
Result
URL related to results and publications
We still analyzing results
Number of participants that the trial has enrolled
90
Results
We still analyzing results
Results date posted
| 2019 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We still analyzing results
Participant flow
We still analyzing results
Adverse events
We still analyzing results
Outcome measures
We still analyzing results
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037453
