UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045145
Receipt number R000051573
Scientific Title New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.
Date of disclosure of the study information 2021/08/12
Last modified on 2021/08/12 20:11:10

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Basic information

Public title

New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.

Acronym

New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.

Scientific Title

New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.

Scientific Title:Acronym

New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.

Region

Japan


Condition

Condition

Polycystic ovary syndrome(PCOS)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We have developed new controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher-quality oocytes and verify on its efficacy and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

To establish a new controlled ovarian stimulation (COS) protocol for polycystic ovary syndrome (PCOS) that does not cause ovarian hyper stimulation syndrome (OHSS) while maintaining egg quality.

Key secondary outcomes

1)No adverse and after effect for ovarian function following using this COS

2)Comparison of proportions of fertilization, pregnancy and abortion with those of base line levels.


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

4

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

In the new COS protocol, we started with FSH injections (150IU/ml) and then continued with HMG (150IU/ml) until the injection of the trigger. GnRH antagonist shots were started when the leading follicle reached 18mm, they continued until the largest follicle was 26-28mm and the E2 level was over 3500 pg/ml. Then leuprorelin acetate (1.88mg) was injected as trigger.
One tablet of Letrozole was used when E2 level was 4000-5000 pg/ml and the total number of follicles was 20-30. Two tablets were used when E2 level was over 5000 pg/ml and there were more than 30 follicles. When E2 level was still over 2000-3000 pg/ml the following day, one tablet of Letrozole was added and trigger was injected on the same day.
In addition, after egg collection, 2 tablets each of Letrozole and Cabergoline and 1 tablet of GnRH antagonist were administered for 5 consecutive days.

Interventions/Control_2

Conventional COS-1
GnRH agonist based COS with HCG Trigger

Interventions/Control_3

Conventional COS-2
GnRH antagonist based COS with HCG Trigger

Interventions/Control_4

Conventional COS-3
GnRH antagonist based COS with GnRH agonist Trigger

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

40 years-old >=

Gender

Female

Key inclusion criteria

1)Patient of Polycystic ovary syndrome(PCOS)
2)Married women

Key exclusion criteria

1)Patients with Severe Type2 diabetes.
2)Patients and Husband who can not obtain written informed consent.
3)Patients judged to be inappropriate for the study by the physicians.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Tanaka

Organization

Saint Mother Clinic

Division name

Medical office

Zip code

807-0825

Address

4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan

TEL

093-601-2000

Email

incho@stmother.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Tanaka

Organization

Saint Mother Clinic

Division name

Medical office

Zip code

807-0825

Address

4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan

TEL

093-601-2000

Homepage URL


Email

incho@stmother.com


Sponsor or person

Institute

Saint Mother Clinic

Institute

Department

Personal name



Funding Source

Organization

Saint Mother 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

Saint Mother Clinic Institutional Review Board

Address

4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan

Tel

0936916004

Email

soumu@stmother.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 08 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 20 Day

Date of IRB

2017 Year 12 Month 20 Day

Anticipated trial start date

2017 Year 12 Month 20 Day

Last follow-up date

2023 Year 03 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

2021 Year 08 Month 12 Day

Last modified on

2021 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name