Infertility
Conditions
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.
Interventions
PROCEDUREduostim vs. two antagonist ovarian stimulations
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.
Sponsors
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to live birth (TTLB) | 36 months | The TTLB was measured as the time from ovarian stimulation to a live birth. |
| 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. |
Outcome results
None listed