UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029564
Receipt No. 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 (Ver. 3)

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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
Obsterics 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
Last 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
Email kamiya@fine.ocn.ne.jp

Public contact
1st 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
Email nanakoiwami@gmail.com

Sponsor
Institute Kamiya Ladies Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033778