UMIN-CTR Clinical Trial

Public title

Ovidrel Syringe 250 microgram Drug Use-Results Survey

Acronym

Drug Use-Results Survey of Ovidrel

Scientific Title

Ovidrel Syringe 250 microgram Drug Use-Results Survey

Scientific Title:Acronym

Drug Use-Results Survey of Ovidrel

Region

Japan

Condition

- Ovulation induction and luteinization in infertile patients with oligo- or anovulation due to a dysfunction in hypothalamic-pituitary system
- Final follicle maturation and early luteinization in Assisted Reproductive Technologies

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate safety and efficacy of Ovidrel in clinical practice

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The incidence of adverse drug reactions and infections, the incidence of serious adverse events, and so on

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

For the indications of Ovidrel, which are ovulation induction and luteinization in anovulation or oligoovulation associated with hypothalamic-pituitary dysfunction and maturation of ovum and luteinization in assisted reproductive technology, patients who receive Ovidrel for the first time and give consent to participation in this survey.
For self-injection at home, patients who received Ovidrel for the first time through self-injection at home.

Key exclusion criteria

Patients with contraindications in the package insert.

Target sample size

320

Name of lead principal investigator

1st name	Hidehiko
Middle name
Last name	Momo

Organization

Merck Biopharma Co., Ltd.

Division name

PMS Planning & Strategy, Medical Department

Zip code

106-0041

Address

Azabudai Hills Mori JP Tower 26F, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041 Japan

TEL

03-6756-0791

Email

hidehiko.momo@merckgroup.com

Name of contact person

1st name	Tatsuya
Middle name
Last name	Ogura

Organization

Merck Biopharma Co., Ltd.

Division name

PMS Planning & Strategy, Medical Department

Zip code

106-0041

Address

Azabudai Hills Mori JP Tower 26F, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041 Japan

TEL

03-6756-0750

Homepage URL

Email

tatsuya.ogura@merckgroup.com

Institute

Merck Biopharma Co., Ltd.

Institute

Department

Personal name

Organization

Merck Biopharma Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Merck Biopharma Co., Ltd.

Address

Azabudai Hills Mori JP Tower 26F, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041 Japan

Tel

03-6756-0750

Email

tatsuya.ogura@merckgroup.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

06

Month

04

Day

URL releasing protocol

not applicable

Publication of results

Unpublished

URL related to results and publications

not applicable

Number of participants that the trial has enrolled

419

Results

Safety analysis set n=419
Age:Median 35.0 years
The incidence of adverse drug reactions:4.06%(17 patients)

Results date posted

2026

Year

03

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patient characteristics (Safety analysis set n=419)
Age:Median 35.0 years

Participant flow

In this drug use-results survey, 419 patients were enrolled from 33 sites by the end of the enrollment. CRFs were collected from all 419 patients who were enrolled. There were no patients who were excluded from the safety analysis set or excluded from the effectiveness analysis set, and all 419 patients were included in the safety analysis set as well as the effectiveness analysis set. Of these 419 patients, 202 had OI and 217 had ART. For the patients who were administered Ovidrel Syringe for the indication of OI, 196 patients were administered Ovidrel Syringe by means other than self-injection at home while 6 patients were administered Ovidrel Syringe through self-injection at home. For the patients who were administered Ovidrel Syringe for the indication of ART, 177 patients were administered Ovidrel Syringe by means other than self-injection at home while 40 patients were administered Ovidrel Syringe through self-injection at home.

Adverse events

The incidence of preferred terms of ADRs that occurred during the observation period, within the 6 weeks after the first dose of Ovidrel Syringe or the day of embryo transfer, in the 419 patients in the safety analysis set was 4.06% (17 of 419 patients) and there were no occurrences of serious ADRs. The ADRs that occurred were OHSS in 13 patients (3.10%), abortion early in 2 patients (0.48%), abdominal discomfort, pruritus, and rash erythematous in 1 patient each (0.24% each). Of these, the incidence of ADRs that occurred during the observation period in the 46 patients who were administered Ovidrel Syringe through self-injection at home was 2.17% (1 of 46 patients). The ADR that occurred was abortion early in 1 patient (2.17%).The incidences of events that occurred during the observation period that correspond to terms listed in "safety specifications" were 3.10% (13 of 419 patients) with OHSS and 0.24% (1 of 419 patients) with allergy/hypersensitivity reactions. Events that occurred corresponding to "allergy/hypersensitivity reactions" were pruritus and rash erythematous in 1 patient (same patient). There was no occurrence of events that correspond to "OHSS and its complications," "thromboembolism," or "reproductive tract cancer (breast cancer, ovarian cancer, endometrial cancer)." In addition, there were no events that correspond to terms listed in "safety specifications" that occurred in the 46 patients who were administered Ovidrel Syringe through self-injection at home.

Outcome measures

Safety
The incidence of preferred terms of ADRs that occurred during the observation period, within the 6 weeks after the first dose of Ovidrel Syringe or the day of embryo transfer, in the 419 patients in the safety analysis set was 4.06% (17 of 419 patients) and there were no occurrences of serious ADRs. The ADRs that occurred were OHSS in 13 patients (3.10%), abortion early in 2 patients (0.48%), abdominal discomfort, pruritus, and rash erythematous in 1 patient each (0.24% each). Of these, the incidence of ADRs that occurred during the observation period in the 46 patients who were administered Ovidrel Syringe through self-injection at home was 2.17% (1 of 46 patients). The ADR that occurred was abortion early in 1 patient (2.17%).The incidences of events that occurred during the observation period that correspond to terms listed in "safety specifications" were 3.10% (13 of 419 patients) with OHSS and 0.24% (1 of 419 patients) with allergy/hypersensitivity reactions. Events that occurred corresponding to "allergy/hypersensitivity reactions" were pruritus and rash erythematous in 1 patient (same patient). There was no occurrence of events that correspond to "OHSS and its complications," "thromboembolism," or "reproductive tract cancer (breast cancer, ovarian cancer, endometrial cancer)." In addition, there were no events that correspond to terms listed in "safety specifications" that occurred in the 46 patients who were administered Ovidrel Syringe through self-injection at home.
Effectiveness
Of the 419 patients in the effectiveness analysis set, the ovulation rate in the patients who were administered Ovidrel Syringe (by means other than self-injection at home) for the indication of OI was 89.29% (175 of 196 patients). The ovulation rate in the patients who were administered Ovidrel Syringe (through self-injection at home) for the indication of OI was 100% (6 of 6 patients). The number of oocytes retrieved (mean +/- standard deviation, hereinafter the same) in the patients who were administered Ovidrel Syringe for the indication of ART, was 6.8 +/- 5.2 in patients who were administered Ovidrel Syringe by means other than self-injection at home (177 patients) and 6.5 +/- 4.8 in patients who were administered Ovidrel Syringe through self-injection at home (40 patients).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

24

Day

Date of IRB

2017

Year

08

Month

24

Day

Anticipated trial start date

2017

Year

09

Month

25

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Drug Use-Results Survey according to the GPSP ordinance

Registered date

2019

Year

06

Month

03

Day

Last modified on

2026

Year

03

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042088