ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility
- Conditions
- Male Infertility
- Interventions
- Other: ICSIOther: Conventional IVF
- Registration Number
- NCT03298633
- Lead Sponsor
- Jie Qiao
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2387
- Infertile couples scheduled for their first or second IVF/ICSI cycle.
- Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%.
- Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment.
- Informed consent obtained.
- Couple with contraindication for IVF or ICSI.
- Couples receiving donor sperm or donor eggs.
- Couples undergoing PGD and PGS.
- Sperm concentration with progressive motility used for insemination <100,000/ml on the day of oocyte retrieval.
- Women with 0 oocytes after oocyte retrieval.
- Using frozen semen.
- Poor fertilization in previous cycle (≤ 25%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracytoplasmic Sperm Injection ICSI On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in group A will undergone Intracytoplasmic Sperm Injection (ICSI) procedure, other standard assisted reproductive treatments are similar and parallel between two groups. Conventional IVF Conventional IVF On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in this group will undergone Conventional In Vitro Fertilization (IVF) procedure, other standard assisted reproductive treatments are similar and parallel between two groups.
- Primary Outcome Measures
Name Time Method Ongoing pregnancy leading to live birth after the first cycle with embryo transfer After 22 weeks of gestation A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).
- Secondary Outcome Measures
Name Time Method Fertilization 16-20 hours after oocyte retrieval Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).
Multiple pregnancy 7 weeks after embryo transfer Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.
Ongoing pregnancy 12 weeks after embryo transfer Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
Available embryo 72 hours after oocyte retrieval Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.
Total fertilization failure 72 hours after oocyte retrieval No oocyte formed 2 PN in this given cycle.
Clinical pregnancy 7 weeks after embryo transfer 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).
Gestational diabetes mellitus (GDM) 24-37 weeks of pregnancy Hypertensive disorders of pregnancy 28-37 weeks of pregnancy Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.
Good quality embryo 72 hours after oocyte retrieval Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation.
Implantation 28 days after embryo transfer Number of gestational sacs observed per embryo transferred.
Miscarriage 22 weeks of gestation Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.
Preterm birth 28-37 weeks of pregnancy Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.
Birth weight Within 2 weeks after live birth 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).
Moderate/severe ovarian hyperstimulation syndrome (OHSS) From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days. 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.
Ectopic pregnancy 7 weeks of gestation Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
Antepartum haemorrhage 28-37 weeks of pregnancy Including placenta previa, placenta accreta and unexplained.
Small for gestational age Within 2 weeks after live birth Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Congenital anomaly Within 2 weeks after live birth Any congenital anomaly will be included.
Perinatal mortality Within 6 weeks after live birth 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.
Neonatal mortality Within 6 weeks after live birth death of a live born baby within 28 days of birth
Large for gestational age Within 2 weeks after live birth Birth weight \>90th centile for gestation, based on standardised ethnicity based charts.
Trial Locations
- Locations (10)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Haidian Maternal and Child Health Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Peking University third Hospital
🇨🇳Beijing, Beijing, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Women's Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China