UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031111 |
|---|---|
| Receipt number | R000035524 |
| Scientific Title | The efficacy of progestin primed ovarian stimulation (PPOS) during controlled ovarian stimulation(COS) for patients with endometriosis |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2022/03/02 11:56:54 |
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Basic information
Public title
The efficacy of progestin primed ovarian stimulation (PPOS) during controlled ovarian stimulation(COS) for patients with endometriosis
Acronym
PPOS for patients with endometriosis
Scientific Title
The efficacy of progestin primed ovarian stimulation (PPOS) during controlled ovarian stimulation(COS) for patients with endometriosis
Scientific Title:Acronym
PPOS 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 during COS for patients with endometriosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
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 (<18mm), 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 trigger day)
6) the incidence of OHSS
7) the viable embryo rate
8) ongoing pregnancy rate, early miscarriage rate, multiple pregnancy 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-vaginal ultrasonography and serum hormone measurements are performed, to follow ultrasound confirmation of the absence of oocytes 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 AMH level over 3.0 ng per ml or a high antral follicle count greater than 15, otherwise 225 IU HMG is used. Follicular monitoring start on day 8 or 9 after HMG administration. This monitoring is performed every 2 to 4 days using a transvaginal 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 follicle size is close to 20 mm in diameter, the final stage of oocyte maturation was triggered using a GnRH agonist or/and HCG. Patients receiving the final trigger (GnRH agonist /HCG) undergo transvaginal ultrasound-guided oocyte retrieval 35 to 37 hours after 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 were administered human menopausal gonadotropin and dydrogesterone per day from day 2 or 3 of the menstrual cycle onward, following ultrasound confirmation of the absence of oocytes larger than 10 mm. The initiating dose of 150 IU per day was used for patients with an AMH level over 3.0 ng per ml or a high antral follicle count greater than 15, otherwise 225 IU HMG was used. Follicular monitoring started on day 8 or 9 of the menstrual cycle. This monitoring was performed every 2 to 4 days using a transvaginal ultrasound examination to check the growing follicular size and the number of follicles.
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
| 43 | 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 smaller than 4cm) diagnosed by imaging.
(The patient with endometrial cysts more than 4cm receive the reduction treatment with operation or medication before IVF-ET start.)
2) woman who give written informed consent before entry into this study.
Key exclusion criteria
1) Patients who documented cycles with no oocyte retrieved, any contraindications to ovarian stimulation treatment and
2) patients who has contraindication to DNG, GnRHa, EP, FSH, HMG, HCG
3) Patients who is judged to be inappropriate for this study by the doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kaimiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive therapy
Zip code
0600003
Address
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
TEL
011-231-2722
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
011-231-2722
Homepage URL
nanakoiwami@gmail.com
Sponsor or person
Institute
Kamiya Ladies Clinic
Institute
Department
Personal name
Funding Source
Organization
Kamiya Ladies Clinic
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
| 2018 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
Results
During this study, no premature LH surge was detected. A smaller number of oocytes were retrieved in the dienogest(DNG) group than in the dydrogesterone(DYG) group (6.18 vs. 9.85); however, the rate of mature oocytes was significantly higher in the DNG group than in the DYG group (89.1% vs. 78.9%). The fertilization rate was comparable between two groups. Therefore, patients taking DNG for PPOS can continue endometriosis treatment and obtain good-quality embryos during COH.
Results date posted
| 2021 | Year | 02 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Participant flow
For the DNG protocol, patients continued DNG and started the COH procedure at their individual discretion. Patients in the DYG group, who were not already receiving continuous hormonal treatment, started DYG simultaneously with ovarian stimulation on the second or third days of their menstrual cycles.
Adverse events
None
Outcome measures
The primary outcome was the fertilization rate among endometriosis patients. The secondary outcomes were the rate of oocyte maturation, the numbers of viable embryos, the clinical pregnancy rate, the ongoing pregnancy rate per frozen embryo transfer cycle, and the early miscarriage rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2022 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035524
