Infertility
Conditions
Keywords
Poseidon criteria, Double stimulation, Cummulative live birth
Brief summary
To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.
Detailed description
The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.
Interventions
PROCEDUREDouble Stimulation Protocol
cummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle
PROCEDUREAntagonist Stimulation Protocol
cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol
Sponsors
Hunan Provincial Maternal and Child Health Care Hospital
Jinghua Hospital of Shenyang
Xinjiang Jiayin Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Guangdong Second Provincial General Hospital
The Affiliated Hospital of Qingdao University
Wuhan Tongji Reproductive Medicine Hospital
Reproductive & Genetic Hospital of CITIC-Xiangya
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9） 2. Women aged ≥20 years old 3. Women who are undergoing their first or second ART cycles 4. Women who are undergoing IVF,ICSI or PGT-A cycles 5. Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3
Exclusion criteria
1. Women with RIF or RSA 2. Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps 3. Women with untreated hydrosalpinx that is visible under pelvic ultrasound 4. Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles 5. Women with a history of canceled FET cycle(s) due to a thin endometrium (\<7mm) 6. Man with operation to get sperm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative live birth rate | 36 months | Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group. |
Secondary
| Measure | Time frame |
|---|---|
| Number of retrieved oocytes | 24 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perinatal complications | 36 months | Number of live births with neonatal complications / number of live births. |
| Cost-effectiveness analysis | 36 months | Cost-effectiveness will be evaluated by comparing the two groups in terms of costs and benefits |
| 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. |
| Total amount of Gn used during ovarian stimulation | 24 months | — |
| Birth weight | 36 months | Weight of newborns at delivery |
| Incidence of obstetric complications | 36 months | Number of pregnancies with complications / number of pregnancies. |
Countries
China
Outcome results
None listed