UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007486
Receipt No. 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 (Ver. 6)

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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
Obsterics 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
Email 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
Email hitamura@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008830