Clinical trial NCT05765968: Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders
Official title: Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Poseidon criteria
Double stimulation
Cummulative live birth
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Hunan Provincial Maternal and Child Health Care Hospital
name: Jinghua Hospital of Shenyang
name: Xinjiang Jiayin Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Guangdong Second Provincial General Hospital
name: The Affiliated Hospital of Qingdao University
name: Wuhan Tongji Reproductive Medicine Hospital
name: Reproductive & Genetic Hospital of CITIC-Xiangya
First posted: 2023-03-13
Enrollment: 1198
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 36 months
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: 24 months
Other outcomes:
measure: Clinical pregnancy rate
timeFrame: 36 months
measure: Incidence of obstetric complications
timeFrame: 36 months
measure: Incidence of perinatal complications
timeFrame: 36 months
measure: Cost-effectiveness analysis
timeFrame: 36 months
measure: Birth weight
timeFrame: 36 months
measure: Total amount of Gn used during ovarian stimulation
timeFrame: 24 months
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
References: