Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
1 other identifier
interventional
260
0 countries
N/A
Brief Summary
To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
ExpectedOctober 23, 2023
October 1, 2023
2 years
October 17, 2023
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative live birth rate
Live birth is defined as the delivery of any alive infant after 22 weeks of gestation after our interventions, and cumulative live birth rate is calculated by the total number of women randomized to the specific group.
36 months
Secondary Outcomes (4)
Time to live birth (TTLB)
36 months
Total amount of Gn used during ovarian stimulation
24 months
Number of retrieved oocytes
24 months
Clinical pregnancy rate
36 months
Study Arms (2)
Dual Stimulation Protocol
EXPERIMENTALDual stimulations were performed during the follicular and luteal phases in the same cycle.
Antagonist Stimulation Protocol
ACTIVE COMPARATORAntagonist stimulations were performed during two consecutive follicular phases in two cycles.
Interventions
Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.
Eligibility Criteria
You may qualify if:
- Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
- Aged from 20 to 44 years
- Body mass index (BMI) from 19 to 32 kg/m2
- No more than two previous IVF cycles were recruited
You may not qualify if:
- Amenorrhoea
- Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
- Women with a partner with an extremely severe sperm anomaly or sperm donor use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
October 23, 2023
Study Start
November 1, 2023
Primary Completion
October 30, 2025
Study Completion (Estimated)
October 30, 2026
Last Updated
October 23, 2023
Record last verified: 2023-10