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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044076
Receipt No. 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 2021/04/29

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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
Obsterics 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
Email 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
Email nanakoiwami@gmail.com

Sponsor
Institute Kamiya Ladies Clinic
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2023 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
2021 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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