A single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among infertility couples with PCOS in China.
A single center, randomized controlled clinical trial will enroll 350 couples with PCOS undergoing their first cycle of IVF. The participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. On day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- IVM protocol, and standard IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Ovarian stimulation will be performed by a standard protocol using gonadotrophin-releasing hormone antagonist (GnRH-ant) in association with recombinant FSH (rFSH) and human chorionic gonadotrophin (hCG).Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be inseminated using ICSI or conventional IVF according to the seman analysis. All embryos will be cultured to blastocyst stage and be vitrified.
Controlled ovarian stimulation protocol will not performed in this group patients. Transvaginal ultrasound scanning was examined on natural cycle to monitor the follicle size in group B participants. Oocyte retrieval was scheduled once the endometrium had reached at least 6 mm in thickness and there was no follicle larger than 10 mm. After oocyte retrieval, the COCs will be cultured for 28-32h in special IVM media in order to get the matured oocytes. All the metaphase II (MII) oocytes were inseminated by means of intracytoplasmic sperm injection (ICSI). All embryos will be cultured to blastocyst stage and be vitrified.
Peking University third Hospital
Beijing, Beijing Municipality, China
the proportion of ongoing pregnancy leading to live birth
number of ongoing pregnancy leading to live birth resulting from the first oocyte retrieval cycle after the randomization ( 6 month) divided by the number of patients with oocyte retrieval
Time frame: after 22 weeks of gestation
implantation
Number of gestational sacs observed per embryo transferred
Time frame: 28 days after embryo transfer
clinical pregnancy
one or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 7 weeks after embryo transfer (including clinical documented ectopic pregnancy)
Time frame: 7 weeks after embryo transfer
Miscarriage
Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age
Time frame: 28 weeks of gestation
Preterm birth
Birth of a fetus delieved after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy
Time frame: 28-37 weeks of pregnancy
Birth weight
Including low birth weight (defined as weight \<2500 gm at birth), very low birth weight (defined as \< 1500 gm at birth), high birth weight (defined as \> 4000 gm at birth) and very high birth weight (defined as \> 4500 gm at birth).
Time frame: within 2 weeks after live birth
Large for gestational age
Birth weight \>90th centile for gestation, based on standardised ethnicity based charts.
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Time frame: within 2 weeks after live birth
Small for gestational age
Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Time frame: within 2 weeks after live birth
Congenital anomaly
Any congenital anomaly will be included diagnosed by physical examinition, ultrasound or necessary testing (including CT, X-ray etc.)
Time frame: within 2 weeks after live birth
Perinatal mortality
Fetal or neonatal death occurring during late pregnancy (at 28 completed weeks of gestational age and later), during childbirth, or up to seven completed days after birth.
Time frame: within 2 weeks after live birth
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian enlargement and respiratory hemodynamic, and metabolic complications. Diagosised by ultrasound, blood testing and physical examination according the Chinese Medical Guildline.
Time frame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.