Assisted Reproductive Techniques
Conditions
Keywords
double ovarian stimulation, low prognosis women, ongoing pregnancy
Brief summary
The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.
Detailed description
The patients will be allocated into two groups: control and study group \_ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved. \_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.
Interventions
PROCEDUREdouble stimulation
the patients will be treated with two consecutive ovarian stimulations in one cycle
PROCEDUREconventional ovarian stimulation
the patients will be treated with one conventional ovarian stimulation in one cycle
Sponsors
Federico II University
University of Medicine and Pharmacy at Ho Chi Minh City
Tu Du Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≤ 40. * AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml. * OR 3 ≤ AFC ≤7. * Normal shape of uterus (based on ultrasound). * Body mass index within 28 - 37 kg/m2
Exclusion criteria
* Asherman's syndrome. * Endometriosis. * Leiomyomas distorting the endometrium * Sperm extracted from surgical procedures (i.e. PESA, TESE). * Patients refuse to continue participating in the study. * Patients injected with wrong dose of gonadotropins during the treatment. * Serious complications or accidents arise forcing the patients to discontinue the treatments. * Ovarian surgery * Previous chemotherapy or pelvic irradiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Ongoing pregnancy rate | week 11 - 14 of pregnancy | calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | week 11 - 14 of pregnancy | defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus |
| Number of oocytes retrieved | 4 hours after occyte pick-up | Number of oocytes retrieved identified by the embryologists |
| Pregnancy rate | 2 weeks after embryo transfer | beta-hCG test is positive |
| Number of competent embryos | 3 days to 5 days after oocyte pick-up | Number of embryos that can be transferred |
| Fertilization rate | 1 to 3 days after oocyte pick-up | number of fertilized oocyted divided by number of mature oocytes |
| Number of mature oocytes | 4 hours after oocyte pick-up | Number of mature oocytes identified by the embryologists |
Countries
Vietnam
Contacts
Primary ContactChau TM Le, PhD
Backup ContactAnh Q Nguyen, Master
Outcome results
None listed