Unique ID issued by UMIN | UMIN000044076 |
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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 |
The efficacy of progestin primed ovarian stimulation (PPOS) using Dienogest v.s. antagonist method during controlled ovarian stimulation(COS) for patients with endometriosis
The efficacy of PPOS using Dienogest
The efficacy of progestin primed ovarian stimulation (PPOS) using Dienogest v.s. antagonist method for patients with endometriosis
PPOS using Diengoest for patients with endometriosis
Japan |
infertility
Obstetrics and Gynecology |
Others
NO
To investigate the clinical efficacy of PPOS using Dienogest forCOS for patients with endometriosis
Efficacy
Confirmatory
Pragmatic
Phase IV
The clinical pregnancy rate
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
42 | years-old | >= |
Female
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.
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
80
1st name | Hirobumi |
Middle name | |
Last name | Kamiya |
Kamiya Ladies Clinic
Reproductive therapy
0600003
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
0112312722
kamiya@fine.ocn.ne.jp
1st name | Nanako |
Middle name | |
Last name | Iwami |
Kamiya Ladies Clinic
Reproductive therapy
0600003
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
0112312722
nanakoiwami@gmail.com
Kamiya Ladies Clinic
Self funding
Self funding
Kamiya Ladies Clinic
2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
011-231-2722
tozawa@kamiyaclinic.com
NO
2021 | Year | 05 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 02 | Month | 01 | Day |
2021 | Year | 04 | Month | 30 | Day |
2021 | Year | 05 | Month | 01 | Day |
2024 | Year | 04 | Month | 30 | Day |
2021 | Year | 04 | Month | 29 | Day |
2023 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050321
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