UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049988 |
|---|---|
| Receipt number | R000056919 |
| Scientific Title | Observational Comparative Trial of Ovarian Stimulation and Pregnancy Outcomes in Japanese Women Undergoing Assisted Reproductive Technology Using Follitropin Delta versus Follitropin Alfa in Progestin-Primed Ovarian Stimulation (PPOS) |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2024/06/26 11:41:24 |
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Basic information
Public title
An Observational Comparative Study of Ovarian Stimulation and Pregnancy Outcomes in Japanese Women Undergoing Assisted Reproductive Technology Using Follitropin Delta versus Follitropin Alfa in Progestin-Primed Ovarian Stimulation (PPOS)
Acronym
Observational Comparative Study of Follitropin Delta and Alfa in PPOS
Scientific Title
Observational Comparative Trial of Ovarian Stimulation and Pregnancy Outcomes in Japanese Women Undergoing Assisted Reproductive Technology Using Follitropin Delta versus Follitropin Alfa in Progestin-Primed Ovarian Stimulation (PPOS)
Scientific Title:Acronym
Comparative Trial of Follitropin Delta and Alfa in PPOS
Region
| Japan |
Condition
Condition
Primary and secondary infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the use of follitropin delta for progestin-primed ovarian stimulation (PPOS) has similar clinical outcomes as follitropin alfa.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of good embryos available for embryo transfer
Key secondary outcomes
1.Proportion of Subjects With Extreme Ovarian Responses
Extreme ovarian response defined as <2, >25 oocytes retrieved. Subjects with cycle cancellation due to poor ovarian response are included as <1 oocytes retrieved.
2.Number of growing Follicles At oocyte retrieval
3. Number of picked up Follicles At oocyte retrieval
4. Percentage of Metaphase2 (M2) Oocytes
5.Fertilization Rate,The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.
6.Number of premature Luteinizing Hormone (LH) surge occurrences
7.Proportion of Subjects With Early Ovarian hyper stimulation syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS (Time Frame: Up to 9 days after triggering of final follicular maturation )
Early OHSS is defined as OHSS with onset <9 days after triggering of final follicular maturation. Classification of grade is according to Golan's classification system, and all OHSS cases are graded as mild, moderate or severe.
8.Circulating Concentrations of Estradiol, Progesterone, LH,FSH
9. Number of Stimulation Days
10.Number of Subjects With Adverse Events
11.Positive Beta Unit of Human Chorionic Gonadotropin (hCG) Rate
Defined as positive hCG test 13-15 days after embryo transfer.
12.Clinical Pregnancy Rate,Defined as at least one gestational sac 5-6 weeks after transfer.
13.Ongoing Pregnancy Rate,Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.
14.Proportion of Subjects With Early Pregnancy Losses
Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).
Frequency of early pregnancy losses are presented.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Written informed consent is obtained from the patients who are enrolled.
2.Age younger than 41 years, willing to undergo assisted reproductive treatment at our clinic
3.Anti-Mullerian hormone (AMH) levels greater than 1.0 ng/ml
4. First or second time of IVF/intra-cytoplasmic sperm injection (ICSI) at our clinic
5.Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
6.In good physical and mental health in the judgement of the investigator.
7.Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
Key exclusion criteria
Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).
One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization)
Patients with untreated hydrosalpinx
Patients with untreated intrauterine lesions (endometrial polyps or submucosal myoma)
Patients with serious primary disease
Patients with uncontrolled diabetes or other endocrine complications
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kamiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive health
Zip code
0600003
Address
Nittsu Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
TEL
+81-11-231-2722
kamiya@fine.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Iwami |
Organization
Kamiya Ladies Clinic
Division name
Reproductive health
Zip code
0600003
Address
Nittsu Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
TEL
+81-231-2722
Homepage URL
iwami@kamiyaclinic.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
Kamiya Ladies Clinic
Address
Nittsu Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan
Tel
+81-11-231-2722
tozawa@kamiyaclinic.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
| 2023 | Year | 01 | Month | 10 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056919
