Back to resultsCumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Primary Purpose
Infertility
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
duostim vs. two antagonist ovarian stimulations
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual Stimulation Protocol
Antagonist Stimulation Protocol
Arm Description
Dual stimulations were performed during the follicular and luteal phases in the same cycle.
Antagonist stimulations were performed during two consecutive follicular phases in two cycles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to live birth (TTLB)
The TTLB was measured as the time from ovarian stimulation to a live birth.
Total amount of Gn used during ovarian stimulation
Total amount of Gn used during ovarian stimulation
Number of retrieved oocytes
Number of retrieved oocytes after ovarian stimulation.
Clinical pregnancy rate
Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Full Information
NCT ID
NCT06093984
First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Shanghai First Maternity and Infant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06093984
Brief Title
Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Official Title
A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital
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 between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.
Detailed Description
Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual Stimulation Protocol
Arm Type
Experimental
Arm Description
Dual stimulations were performed during the follicular and luteal phases in the same cycle.
Arm Title
Antagonist Stimulation Protocol
Arm Type
Active Comparator
Arm Description
Antagonist stimulations were performed during two consecutive follicular phases in two cycles.
Intervention Type
Procedure
Intervention Name(s)
duostim vs. two antagonist ovarian stimulations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Time to live birth (TTLB)
Description
The TTLB was measured as the time from ovarian stimulation to a live birth.
Time Frame
36 months
Title
Total amount of Gn used during ovarian stimulation
Description
Total amount of Gn used during ovarian stimulation
Time Frame
24 months
Title
Number of retrieved oocytes
Description
Number of retrieved oocytes after ovarian stimulation.
Time Frame
24 months
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
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