Infertility
Conditions
Keywords
GnRH antagonist, Estrogen pretreatment, Poor response patient
Brief summary
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
Detailed description
Women of advanced maternal age seeking ART treatment are characterized as poor ovarian responders in the process of ovarian simulation. Poor response to ovarian stimulation causes high cycle cancellation rate and extremely low pregnancy rate. More attention has been paid to the potential interest of steroid pretreatments in GnRH antagonist cycles; not only for scheduling the GnRH antagonist cycles, but also for synchronizing the follicular growth which may result in more oocytes retrieved. But available clinical results are controversial. Previous studies have shown that utilizing the natural negative feedback of the hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively prevented inter-cycle increases in follicle-stimulating hormone, improved follicle synchronization, and resulted in a more coordinated follicular development, leading to the recovery of more mature oocytes. However none of the randomized controlled studies compared estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate, directly on poor response patients using estradiol valerate pretreatment in GnRH antagonist protocol.
Interventions
DRUGFollitropin Beta;MSD
Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.
DRUGGanirelix
A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.
DRUGhCG
Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger
DRUGestradiol valerate
Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle
Sponsors
Merck Sharp & Dohme LLC
Reproductive & Genetic Hospital of CITIC-Xiangya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of oocytes retrieved by the IVG 36 hours after hCG administration | 36 hours after hCG administration | The total MII oocytes retrievedd |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6weeks | 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. |
| ongoing pregnancy rate | 12weeks | ongoing pregnancy defined as an intact pregnancy at 12 weeks of gestation |
| Optimal number of embryo | 1 week | 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 |
Countries
China
Outcome results
None listed