UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044076 |
|---|---|
| Receipt number | R000050321 |
| Scientific Title | Comparison of Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocols during Continuous Dienogest Administration in Endometriosis-Associated Infertility: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2024/06/26 11:20:41 |
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Basic information
Public title
Comparison of progestin-primed ovarian stimulation (PPOS) during continuous dienogest administration and GnRH antagonist method in infertility cases complicated by endometriosis: A retrospective cohort Study
Acronym
Retrospective Cohort Study of PPOS vs GnRH Antagonist during Dienogest Administration
Scientific Title
Comparison of Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocols during Continuous Dienogest Administration in Endometriosis-Associated Infertility: A Retrospective Cohort Study
Scientific Title:Acronym
Retrospective Cohort Study Comparing PPOS and GnRH Antagonist Methods during Dienogest Administration
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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 2025 | 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
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050321
