UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of reulgolix in controlled ovarian stimulation cycles
Acronym	Efficacy of reulgolix in controlled ovarian stimulation cycles
Scientific Title	Efficacy of reulgolix in controlled ovarian stimulation cycles
Scientific Title:Acronym	Efficacy of reulgolix in controlled ovarian stimulation cycles
Region	Japan

Condition
Condition	infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the efficacy of relugolix in controlled ovarian stimulation cycles.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of retrieved oocytes.
Key secondary outcomes	The number of mature oocytes (metaphase II). The number of cleavage stage embryos (Veeck's classification 1 to 3) The detail of adverse-event

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	cetrorelix acetate (Cetrotide; Merck Biopharma Co., Ltd., Tokyo, Japan) 0.25 mg/day or ganirelix acetate (GANIREST; MSD KK a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA) 0.25 mg/day
Interventions/Control_2	40 mg/day of relugolix (RELUMINA; ASKA Pharmaceutical Co., Ltd., Tokyo, Japan)
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) patients who were scheduled for oocyte retrieval at our clinic and planned to undergo a COS cycle with an antagonist or natural protocols, and 2) patients who could provide written consent
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shinnosuke Middle name Last name Komiya
Organization	HORAC Grand Front Osaka Clinic
Division name	Gynecology
Zip code	5300011
Address	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL	+81663778824
Email	komiya520@ivfjapan.com

Public contact
Name of contact person	1st name Shinnosuke Middle name Last name Komiya
Organization	HORAC Grand Front Osaka Clinic
Division name	Gynecology
Zip code	5300011
Address	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL	+81663778824
Homepage URL
Email	komiya520@ivfjapan.com

Sponsor
Institute	HORAC Grand Front Osaka Clinic
Institute
Department

Funding Source
Organization	HORAC Grand Front Osaka 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	HORAC Grand Front Osaka Clinic
Address	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
Tel	+81663778824
Email	komiya520@ivfjapan.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 09 Month 29 Day

Related information
URL releasing protocol	none
Publication of results	Unpublished

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12448
Number of participants that the trial has enrolled	785
Results	The number of retrieved oocytes in the relugolix group was similar to that in the control group when serum E2 values were < 3,000 pg/mL (p = 0.86). However, the number of retrieved oocytes in the relugolix group was significantly lower than that in the control group when serum E2 values were > 3,000 pg/mL (p = 0.04).
Results date posted	2021 Year 09 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 02 Month 17 Day
Baseline Characteristics	There were no significant differences in the patients' background data, except for the LH concentration on the trigger day.
Participant flow	A total of 1,739 COS cycles in the antagonist or natural protocol were obtained during the inclusion period, and 18 (1.0 %) were canceled owing to an inadequate ovarian response to stimulation. Finally, 1,721 COS cycles were analyzed.
Adverse events	In the relugolix group, four (1.6%) patients had fatigue and mild headache, but there were no severe cases. There were also no cases of apparent intra-abdominal hemorrhage, severe ovarian hemorrhage, intra-abdominal infection, or severe OHSS, although there was minor vaginal wall bleeding during oocyte retrieval.
Outcome measures	The number of retrieved oocytes in the relugolix group was similar to that in the control group when serum E2 values were < 3,000 pg/mL (p = 0.86). However, the number of retrieved oocytes in the relugolix group was significantly lower than that in the control group when serum E2 values were > 3,000 pg/mL (p = 0.04). The same results were obtained when the evaluation measurements were the number of mature oocytes and the number of embryos at the cleavage stage.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 01 Month 10 Day
Anticipated trial start date	2019 Year 01 Month 20 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry	2020 Year 10 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 29 Day
Last modified on	2022 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052069