UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029564 |
|---|---|
| Receipt number | R000033778 |
| Scientific Title | The efficacy of dydrogesterone and human menopausal gonadotropin protocol for ART |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2019/04/18 01:33:16 |
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Basic information
Public title
The efficacy of dydrogesterone and human menopausal gonadotropin protocol for ART
Acronym
Dydrogesteone new protocol
Scientific Title
The efficacy of dydrogesterone and human menopausal gonadotropin protocol for ART
Scientific Title:Acronym
Dydrogesteone new protocol
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 our new protocol using dydrogesterone with human menopausal gonadotropin for patients undergoing controlled ovarian stimulation in comparison with GnRHantagonist protocol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
The clinical pregnancy rate
Key secondary outcomes
The number of oocytes retrieved, the fertilization rate, the incidence of premature LH surge, the rate of viable embryos, the ongoing 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, 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_2
In the control group, patients were administered human menopausal gonadotropin on day 2 or 3 of the menstrual cycle. The choice of the first human menopausal gonadotropin dose was decided in the same manner as the study group. When either the leading follicle reached 14 mm or serum E2 levels exceeded 1000 pg per ml, a GnRH antagonist was administered every 24 hours to suppress premature LH surges following a flexible protocol.
The ultrasound examination and serum hormone level test were initiated on day 8 or 9 of the menstrual cycle, and the dose of HMG was 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
| 41 | years-old | >= |
Gender
Female
Key inclusion criteria
Written informed consent is obtained from the patients who are enrolled. Inclusion criteria were as follows: age younger than 41 years, anti-Mullerian hormone (AMH) levels greater than 1.0 ng/ml, first or second time of IVF/intra-cytoplasmic sperm injection (ICSI) at our clinic.
Key exclusion criteria
Patients who had endometriosis grade 3 or higher, documented cycles with no oocyte retrieved, and any contraindications to ovarian stimulation treatment.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirobumi Kaimiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive therapy
Zip code
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 | |
| Middle name | |
| Last name | Nanako Iwami |
Organization
Kamiya Ladies Clinic
Division name
Reproductive therapy
Zip code
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
Address
Tel
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
| 2017 | Year | 10 | Month | 20 | 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
Results
The subjects were 299 women undergoing COS for IVF/ICSI, between July 2016 and April 2017.No significant difference was found in the number of oocytes retrieved (control group: 10.74vs. study group: 10.87, p=0.5461) or viable embryo rate (control group: 68.1% vs. study group: 65.5%, p=0.2161) between the two groups. In the study group, During the follow-up period of FET, a total of 262 FET cycles were completed. At this time, there were no significant differences in the clinical pregnancy rate (49.3% vs. 57.4%, p=0.1905), implantation rate (45.2% vs. 51.7%, p=0.3977), ongoing pregnancy rate (40.7% vs. 45.2%), and early pregnancy loss rate (17.4% vs. 20.0%, p=0.6933) between the control and study groups.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033778
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