Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
- Conditions
- Infertility
- Interventions
- Procedure: duostim vs. two antagonist ovarian stimulations
- Registration Number
- NCT06093984
- Lead Sponsor
- Shanghai First Maternity and Infant Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 260
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dual Stimulation Protocol duostim vs. two antagonist ovarian stimulations Dual stimulations were performed during the follicular and luteal phases in the same cycle. Antagonist Stimulation Protocol duostim vs. two antagonist ovarian stimulations Antagonist stimulations were performed during two consecutive follicular phases in two cycles.
- Primary Outcome Measures
Name Time Method Cumulative live birth rate 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 Outcome Measures
Name Time Method Total amount of Gn used during ovarian stimulation 24 months Total amount of Gn used during ovarian stimulation
Number of retrieved oocytes 24 months Number of retrieved oocytes after ovarian stimulation.
Clinical pregnancy rate 36 months Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Time to live birth (TTLB) 36 months The TTLB was measured as the time from ovarian stimulation to a live birth.