Back to resultsCumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders
Primary Purpose
Infertility
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Double Stimulation Protocol
Antagonist Stimulation Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Poseidon criteria, Double stimulation, Cummulative live birth
Eligibility Criteria
Inclusion Criteria: Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9） Women aged ≥20 years old Women who are undergoing their first or second ART cycles Women who are undergoing IVF,ICSI or PGT-A cycles Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3 Exclusion Criteria: Women with RIF or RSA Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps Women with untreated hydrosalpinx that is visible under pelvic ultrasound Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm) Man with operation to get sperm
Sites / Locations
- Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Double Stimulation Protocol
Antagonist Stimulation Protocol
Arm Description
Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH&hmg.
The classical antagonist protocol were performed by rFSH,hmg and antagonist.
Outcomes
Primary Outcome Measures
Cumulative live birth rate
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
Secondary Outcome Measures
Number of retrieved oocytes
Full Information
NCT ID
NCT05765968
First Posted
February 28, 2023
Last Updated
March 12, 2023
Sponsor
Shandong University
Collaborators
Hunan Provincial Maternal and Child Health Care Hospital, Jinghua Hospital of Shenyang, Xinjiang Jiayin Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, Wuhan Tongji Reproductive Medicine Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya
1. Study Identification
Unique Protocol Identification Number
NCT05765968
Brief Title
Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders
Official Title
Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 14, 2023 (Anticipated)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Hunan Provincial Maternal and Child Health Care Hospital, Jinghua Hospital of Shenyang, Xinjiang Jiayin Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, Wuhan Tongji Reproductive Medicine Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.
Detailed Description
The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Poseidon criteria, Double stimulation, Cummulative live birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double Stimulation Protocol
Arm Type
Experimental
Arm Description
Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH&hmg.
Arm Title
Antagonist Stimulation Protocol
Arm Type
Active Comparator
Arm Description
The classical antagonist protocol were performed by rFSH,hmg and antagonist.
Intervention Type
Procedure
Intervention Name(s)
Double Stimulation Protocol
Intervention Description
cummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle
Intervention Type
Procedure
Intervention Name(s)
Antagonist Stimulation Protocol
Intervention Description
cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Description
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Number of retrieved oocytes
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Clinical pregnancy rate
Description
Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Time Frame
36 months
Title
Incidence of obstetric complications
Description
Number of pregnancies with complications / number of pregnancies.
Time Frame
36 months
Title
Incidence of perinatal complications
Description
Number of live births with neonatal complications / number of live births.
Time Frame
36 months
Title
Cost-effectiveness analysis
Description
Cost-effectiveness will be evaluated by comparing the two groups in terms of costs and benefits
Time Frame
36 months
Title
Birth weight
Description
Weight of newborns at delivery
Time Frame
36 months
Title
Total amount of Gn used during ovarian stimulation
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
Women aged ≥20 years old
Women who are undergoing their first or second ART cycles
Women who are undergoing IVF,ICSI or PGT-A cycles
Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3
Exclusion Criteria:
Women with RIF or RSA
Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
Women with untreated hydrosalpinx that is visible under pelvic ultrasound
Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm)
Man with operation to get sperm
Facility Information:
Facility Name
Shandong University
City
Jinan
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders
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