UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044076 |
|---|---|
| Receipt number | R000050321 |
| Scientific Title | The efficacy of progestin primed ovarian stimulation (PPOS) using Dienogest v.s. antagonist method for patients with endometriosis |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2023/05/01 15:20:21 |
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Basic information
Public title
The efficacy of progestin primed ovarian stimulation (PPOS) using Dienogest v.s. antagonist method during controlled ovarian stimulation(COS) for patients with endometriosis
Acronym
The efficacy of PPOS using Dienogest
Scientific Title
The efficacy of progestin primed ovarian stimulation (PPOS) using Dienogest v.s. antagonist method for patients with endometriosis
Scientific Title:Acronym
PPOS using Diengoest for patients with endometriosis
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of PPOS using Dienogest forCOS for patients with endometriosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The clinical pregnancy rate
Key secondary outcomes
1) total amount of FSH/HMG
2) number of growing follicle (<15mm) and mature follicle (<18m m), number of oocyte retrieved
3)the incidence of premature LH surge
4) fertilization rate, implantation rate
5) serum concentration of estradiol and progesterone (on the tri gger day)
6) the incidence of OHSS
7) the viable embryo rate
8) ongoing pregnancy rate, early miscarriage rate, multiple preg nancy rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the study group, Dienogest (2mg/day 1mg tablet 2 times/day) is administered orally from the previous cycle. And trans-vagina l ultrasonography and serum hormone measurements are performed, to follow ultrasound confirmation of the absence of oocyte s larger than 10 mm with serum E2 <70pg/ml. After that patients are administered human menopausal gonadotropin per day. The initiating dose of 150 IU per day is used for patients with an AM H level over 3.0 ng per ml or a high antral follicle count greater than 15, otherwise 225 IU HMG is used. Follicular monitoring st art on day 8 or 9 after HMG administration. This monitoring is performed every 2 to 4 days using a trans-vaginal ultrasound examination to check the growing follicular size and the number of follicles. The HMG dose is increased by 75 IU when the growing speed of follicles is assessed as slow. When the main dominant f ollicle size is close to 20 mm in diameter, the final stage of oocyt e maturation was triggered using a GnRH agonist or/and HCG. P atients receiving the final trigger (GnRH agonist /HCG) undergo t ransvaginal ultrasound-guided oocyte retrieval 35 to 37 hours af ter the trigger. All follicles with diameters larger than 10 mm are aspirated. All high quality embryos are cryopreserved for later transfer.
Interventions/Control_2
In the control group, patients are administered human menopousal gonadotropin on day 2 or 3 of the menstrual cycle. The choice of the first human menopausal gonadotropin dose is decided in the same manner as the study group. When either the lead ing follicle reach 14 mm or serum E2 levels exceed1000 pg per ml, a GnRH antagonist is administered every 24 hours to suppress premature LH surges following a flexible protocol.
The ultrasound examination and serum hormone level test are initiated on day 8 or 9 of the menstrual cycle, and the dose of H MG is adjusted according to follicular development.
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
| 42 | 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 diam eter smaller than 4cm) diagnosed by imaging.
(The patient with endometrial cysts more than 4cm receive the r eduction treatment with operation or medication before IVF-ET start.)
2) woman who give written informed consent before entry into t his study.
Key exclusion criteria
1) Patients who documented cycles with no oocyte retrieved, an y contraindications to ovarian stimulation treatment and
2) patients who has contraindication to DNG, GnRHa, EP, FSH, HMG, HCG
3) Using other hormonal therapy except Dienogest over 2 months before COS
4) Patients who is judged to be inappropriate for this study by th e doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kamiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive therapy
Zip code
0600003
Address
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
TEL
0112312722
kamiya@fine.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Iwami |
Organization
Kamiya Ladies Clinic
Division name
Reproductive therapy
Zip code
0600003
Address
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
TEL
0112312722
Homepage URL
nanakoiwami@gmail.com
Sponsor or person
Institute
Kamiya Ladies Clinic
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
Kamiya Ladies Clinic
Address
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
Tel
011-231-2722
tozawa@kamiyaclinic.com
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
| 2021 | Year | 05 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050321
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