A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.
A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional 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
2,387
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo routine ICSI procedure according to the result of randomization in each study site.
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo conventional IVF procedure according to the result of randomization in each study site.
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University third Hospital
Beijing, Beijing Municipality, China
Haidian Maternal and Child Health Hospital
Beijing, Beijing Municipality, China
Ongoing pregnancy leading to live birth after the first cycle with embryo transfer
A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).
Time frame: After 22 weeks of gestation
Fertilization
Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).
Time frame: 16-20 hours after oocyte retrieval
Total fertilization failure
No oocyte formed 2 PN in this given cycle.
Time frame: 72 hours after oocyte retrieval
Available embryo
Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.
Time frame: 72 hours after oocyte retrieval
Good quality embryo
Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation.
Time frame: 72 hours after oocyte retrieval
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 clinically documented ectopic pregnancy).
Time frame: 7 weeks after embryo transfer
Multiple pregnancy
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The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Women's Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.
Time frame: 7 weeks after embryo transfer
Ongoing pregnancy
Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
Time frame: 12 weeks after embryo transfer
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.
Time frame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.
Miscarriage
Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.
Time frame: 22 weeks of gestation
Ectopic pregnancy
Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
Time frame: 7 weeks of gestation
Gestational diabetes mellitus (GDM)
Time frame: 24-37 weeks of pregnancy
Hypertensive disorders of pregnancy
Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.
Time frame: 28-37 weeks of pregnancy
Antepartum haemorrhage
Including placenta previa, placenta accreta and unexplained.
Time frame: 28-37 weeks of pregnancy
Preterm birth
Birth of a fetus delivered 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.
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.
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 6 weeks after live birth
Neonatal mortality
death of a live born baby within 28 days of birth
Time frame: Within 6 weeks after live birth