UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005234 |
|---|---|
| Receipt number | R000006125 |
| Scientific Title | Prospective randomized study of IVF-ET with GnRHa long protocol or Dienogest treatment before GnRHa long protocol in patients with endometriosis |
| Date of disclosure of the study information | 2011/03/10 |
| Last modified on | 2020/05/07 17:15:31 |
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Basic information
Public title
Prospective randomized study of IVF-ET with GnRHa long protocol or Dienogest treatment before GnRHa long protocol in patients with endometriosis
Acronym
The effectiveness of Dienogest treatment before IVF-ET in infertile patients with endometriosis.
Scientific Title
Prospective randomized study of IVF-ET with GnRHa long protocol or Dienogest treatment before GnRHa long protocol in patients with endometriosis
Scientific Title:Acronym
The effectiveness of Dienogest treatment before IVF-ET in infertile patients with endometriosis.
Region
| Japan |
Condition
Condition
infertile women, endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endometriosis is understood to be the most intractable cause of female infertility. It has been reported that poor oocyte quality, low fertilization rates, poor embryo quality and impaired implantation of endometriosis patients relate to their poor pregnancy outcomes. This study was undertaken to evaluate the effectiveness of Dienogest (a selective progestin that has been used for the treatment of endometriosis) treatment immediately before in vitro fertilization and embryo transfer (IVF-ET) in infertile patients with endometriosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
pregnancy rate
Key secondary outcomes
1) total amount of FSH/HMG
2) number of growing follicle (<15mm) and mature follicle (<18mm), number of oocyte retrieved
3) fertilization rate, implantation rate
4) serum concentration of estradiol and progesterone (on the day hCG injection)
5) intrafollicular concentration of cytokines (interleukin-6, tumor necrosis factor alpha), oxidative stress markers (8-htdroxy-2'-deoxyguanosine, hexanoyl-lysine), Cu,Zn-superoxide dismutase
6) serum concentration of CA125
7) concentration of interleukin-6 and tumor necrosis factor alpha in peritoneal fluids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
L group: Long protocol group (control group: without DNG)
Gonadotropin-releasing hormone agonist (GnRHa, 900 micro g/day) is given from the mid-luteal phase in the previous cycle to the ovulation induction by HCG. Ovarian stimulation is initiated from 2nd day of the IVF-ET cycle, 225 IU follicle stimulating hormone (FSH) for 3days, and thereafter 150 IU human menopausal gonadotropin (HMG). Oocyte retrieval is carried out 35 h after HCG injection. Each mature follicle (more than 18 mm in diameter) is aspirated separately and the follicular fluid containing the oocyte was collected. Immediately after removal of the oocyte, each follicular fluid is centrifuged to remove cellular components, and the supernatant is obtained.
Interventions/Control_2
D group: Dienogest (DNG) group
Dienogest (2mg/day 1mg tablet 2 times/day) is administered orally for three months until the mid-luteal phase in the previous cycle, and followed by GnRHa for standardized IVF-ET long protocol. Ovarian stimulation and oocyte retrieval are same as L 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
Endometriosis-associated infertile women who undergo IVF-ET program.
1) woman who has endometrioid cyst (chocolate cyst) (cyst diameter < 4cm) diagnosed by imaging.
2) woman who give written informed consent before entry into this study.
Key exclusion criteria
1) patients who had GnRHa ultra long protocol last 6th month
2) patients who had DNG and/or EP treatment or GnRHa treatment ( > 3 month)for endometriosis
3) patients who has undiagnostic genital bleeding
4) a pregnant woman
5) patients who has estrogen dependence tumor (breast cancer, endometrial cancer)
6) patients who has history of breast cancer
7) patients who has Thrombophlebitis and/or Pulmonary thrombosis, or history of these disease.
8) patients who has the thromboembolism disease of the artery (coronary heart disease, Cerebral apoplexy) or history of these disease
9) patients who has liver dysfunction, or liver disease
10) patients who has Hypersensitivity to DNG, GnRHa, EP, FSH, HMG, HCG
11) patients who is judged to be inappropriate for this study by the doctor
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
Obstetrics&Gynecology
Zip code
755-8505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2289
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
Obstetrics&Gynecology
Zip code
755-8505
Address
Minamikogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2289
Homepage URL
hitamura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mochida Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee/Institutional Review Board of Yamaguchi University School of Medicine
Address
Minamikogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan
Tel
0836-22-2428
me223@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
済生会下関総合病院 Saiseikai Shimonoseki General Hospital
吉田レディースクリニック Yoshida Lady's Clinic
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.1186/s13048-019-0597-y
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s13048-019-0597-y
Number of participants that the trial has enrolled
68
Results
The numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts were significantly lower in the DNG group than in the control group. The fertilization and blastocyst rates were also lower in the DNG group than in the control group. Although there was no significant difference in the implantation rate between the groups, the cumulative pregnancy rate and live birth rate were lower in the DNG group than in the control group.
Results date posted
| 2020 | Year | 05 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 12 | Day |
Baseline Characteristics
The study inclusion criteria were as follows: infertile women 20 to 40 years of age with endometrial ovarian cysts (<4 cm) diagnosed by ultrasonography or MRI or laparoscopy. The stage of endometriosis (stage III or IV) was defined by the revised American Society for Reproduction Medicine (rASRM) classification via laparoscopy. Women using hormonal contraceptives or other hormonal therapies or who had a disease condition that might interfere with the conduct of the study were excluded. A total of 68 women were therefore included in this study.
Participant flow
The subjects were randomized to either the DNG group or control group using the envelope method with envelopes distributed by the Department of Obstetrics and Gynecology at Yamaguchi University School of Medicine to each facility (DNG group: 33 cases, control group: 35 cases).
Adverse events
none
Outcome measures
Age, stage of endometriosis (rASRM), serum CA125, total amount of FSH (HMG), The numbers of mature follicles, retrieved oocytes, and fertilized oocytes as well as the fertilization rates, implantation rates, and clinical pregnancy rates.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 10 | 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=R000006125
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