UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007486 |
|---|---|
| Receipt number | R000008830 |
| Scientific Title | Effects of long-term gonadotropin-releasing hormone agonist treatment on the pregnancy outcome of IVF-ET in infertile patients with endometriosis. |
| Date of disclosure of the study information | 2012/03/12 |
| Last modified on | 2020/05/07 17:09:01 |
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Basic information
Public title
Effects of long-term gonadotropin-releasing hormone agonist treatment on the pregnancy outcome of IVF-ET in infertile patients with endometriosis.
Acronym
long-term gonadotropin-releasing hormone agonist treatment for patients with endometriosis.
Scientific Title
Effects of long-term gonadotropin-releasing hormone agonist treatment on the pregnancy outcome of IVF-ET in infertile patients with endometriosis.
Scientific Title:Acronym
long-term gonadotropin-releasing hormone agonist treatment for patients with endometriosis.
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of long-term gonadotropin-releasing hormone agonist (GnRHa) treatment before IVF-ET in infertile patients with endometriosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
pregnancy rate
Key secondary outcomes
number of growing follicle, mature follicle and oocyte retrieved.
fertilization rate
implantation rate
concentrations of cytokines and oxidative stress markers in follicular fluids.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
long-term GnRHa treatment (LG group)
Interventions/Control_2
long protocol (control group)
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
Infertile patients with endometriosis.
patients undergoing in vitro fertilization and embryo transfer (IVF-ET) program.
Key exclusion criteria
Patients were nonsmokers and free from major medical illness including hypertension.
Patients were excluded if they had myoma, adenomyosis, a congenital uterine anomaly, or if they used any kind of sex-steroidal agent including estrogens, progesterone, androgens, and OC.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Sugino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
755-8505
Address
Minamikogushi 1-1-1, Ube, 755-8505 Japan
TEL
+81-836-22-2288
sugino@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tamura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
755-8505
Address
Minamikogushi 1-1-1, Ube, 755-8505 Japan
TEL
+81-836-22-2288
Homepage URL
hitamura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Ministry of Education, Science, and Culture, Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Graduate School of Medicine
Address
Minamikogushi 1-1-1, Ube, 755-8505 Japan
Tel
0832-22-2288
hitamura@yamaguchi-u.ac.jp
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
Yamaguchi University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
https://doi.org/10.1186/s13048-014-0100-8
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s13048-014-0100-8
Number of participants that the trial has enrolled
23
Results
The numbers of mature follicles and retrieved oocytes, and fertilization rates did not differ between the two groups. Implantation rates and pregnancy rates tended to be higher in the UL group compared with the C group. TNFa and 8OHdG concentrations in the follicular fluid were significantly lower in the UL group than those in the C group, while melatonin concentrations were significantly higher in the UL group compared with the C group.
Results date posted
| 2020 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 10 | Month | 21 | Day |
Baseline Characteristics
Twenty-three infertile female patients with endometriosis were recruited for this study. Severity of endometriosis was scored according to the four-stage classification of the revised American Society for Reproductive Medicine (rASRM) score, and all patients had stage III or IV endometriosis.
Participant flow
Eleven patients received three courses of GnRHa (1.8 mg s.c. every 28 days), followed by a standard controlled ovarian hyperstimulation (COH) for IVF-ET (ultralong group). The other 12 patients received a standard COH with mid-luteal phase GnRHa down-regulation (control group).
Adverse events
none
Outcome measures
The numbers of matured follicles and retrieved oocytes, fertilization rates, implantation rates, clinical pregnancy rate, and intrafollicular concentrations of TNFa, 8-OHdG and hexanoyl-lysine adduct (HEL) as oxidative stress markers, and melatonin and Cu,Zu-superoxide dismutase (Cu,Zn-SOD) as antioxidants
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2007 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 21 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 21 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008830
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