UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001051 |
|---|---|
| Receipt number | R000001261 |
| Scientific Title | COMPARISON OF PREGNANCY OUTCOME IN OOCYTE RECIPIENTS AFTER GNRH ANTAGONIST TREATMENT IN THE PROLIPHERATIVE PHASE |
| Date of disclosure of the study information | 2008/02/25 |
| Last modified on | 2008/02/29 20:19:12 |
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Basic information
Public title
COMPARISON OF PREGNANCY OUTCOME IN OOCYTE RECIPIENTS AFTER GNRH ANTAGONIST TREATMENT IN THE PROLIPHERATIVE PHASE
Acronym
PREGNANCY RATES AFTER GNRH ANTAGONIST ADMINISTRATION
Scientific Title
COMPARISON OF PREGNANCY OUTCOME IN OOCYTE RECIPIENTS AFTER GNRH ANTAGONIST TREATMENT IN THE PROLIPHERATIVE PHASE
Scientific Title:Acronym
PREGNANCY RATES AFTER GNRH ANTAGONIST ADMINISTRATION
Region
| Europe |
Condition
Condition
IN VITRO FERTILIZATION CYCLES
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
INVESTIGATE THE EFFECT OF GNRH ANTAGONISTS ON PREGNANCY OUTCOME
Basic objectives2
Others
Basic objectives -Others
EFFECT ON CLINICAL OUTCOME
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
PREGNANCY RATES
Key secondary outcomes
IMPLANTATION RATES, MISCARRIAGE RATES, ENDOMETRIAL THICKNESS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TREATMENT WITH GNRH ANTAGONIST
Interventions/Control_2
NO TREATMENT
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
MENOPAUSAL WOMEN, AT LEAST 6 OOCYTES FROM THE DONOR TO PROCEED WITH IVF CYCLES
Key exclusion criteria
THREE PREVIOUS FAILED ivf CYCLES, UTERINE MALFORMATION,
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NIKOS PRAPAS |
Organization
IAKENTRO FERTILITY CENTRE/ 4TH DEP OBS AND GYNAE-IPPOKRATION GEN HOSPITAL
Division name
PRVIVATE FERTILITY CENTRE
Zip code
Address
AG VASILIOU 4 STR/ 54250 THESSALONIKI/GREECE
TEL
+302310325525
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ASIMINA TAVANIOTOU |
Organization
IAKENTRO FERTILITY CENTRE
Division name
PRIVATE FERTILITY CENTRE
Zip code
Address
AG VASILIOU 4 STR/ 54250 THESSALONIKI GREECE
TEL
+302310325525
Homepage URL
mtavaniotou@hotmail.com
Sponsor or person
Institute
IAKENTRO FERTILITY CENTRE
Institute
Department
Personal name
Funding Source
Organization
SELF FUNDING
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
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
| 2008 | Year | 02 | Month | 25 | 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
NO DIFFERENCE IN PREGNANCY RATES BETWEEN THE TWO GROUPS
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
| 2004 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 25 | Day |
Last modified on
| 2008 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001261
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
