A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 260
- Primary Endpoint
- Cumulative live birth rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cumulative live birth rate
Time Frame: 36 months
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 Outcomes
- Total amount of Gn used during ovarian stimulation(24 months)
- Number of retrieved oocytes(24 months)
- Clinical pregnancy rate(36 months)
- Time to live birth (TTLB)(36 months)