Infertility Clinical Trial
Official title:
A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient
Verified date | January 2022 |
Source | Reproductive & Genetic Hospital of CITIC-Xiangya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none pretreatment GnRH antagonist protocol for the number of oocytes retrieval
Status | Completed |
Enrollment | 552 |
Est. completion date | August 18, 2021 |
Est. primary completion date | June 18, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 45 Years |
Eligibility | Inclusion Criteria:Bologna criteria - At least two of the following three features must be present: 1. Advanced maternal age (=40 years) or any other risk factor for POR 2. A previous POR (=3 oocytes with a conventional stimulation protocol) 3. An abnormal ovarian reserve test (i.e. antral follicle count < 5-7 follicles or AMH< 0.5 - 1.1 ng/mL) Exclusion Criteria: 1. Age =45 years, 2. Patients who conducted PGD/PGS, and donor egg cycles were excluded. 3. Presence of unilateral ovary absence 4. Abnormal uterine deformity or structure. 5. Spontaneous abortion patients with three or more (including biochemical pregnancy abortion) 6. With other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction 7. Have assisted reproductive technology contraindications or pregnancy contraindication of patients |
Country | Name | City | State |
---|---|---|---|
China | Reproductive & Genetic Hospital of Citic-Xiangya | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Reproductive & Genetic Hospital of CITIC-Xiangya | Merck Sharp & Dohme Corp. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of oocytes retrieved by the IVG 36 hours after hCG administration | The total MII oocytes retrievedd | 36 hours after hCG administration | |
Secondary | Clinical pregnancy rate | clinical pregnancy, defined as intrauterine pregnancy with a positive heartbeat at 6 weeks of gestation.Clinical pregnancy rate:Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. When clinical pregnancy rates are given, the denominator must be specified. | 6weeks | |
Secondary | ongoing pregnancy rate | ongoing pregnancy defined as an intact pregnancy at 12 weeks of gestation | 12weeks | |
Secondary | Optimal number of embryo | According to the embryonic developmental rate and morphology, the high quality embryos were defined as the next day (D2) transplanted embryos reached 3 or 4 cells and the third day (D3) transplanted embryos reached 6 to 8 cells with morphological grade 1 or 2 | 1 week |
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