Clinical trial NCT03298633: ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility
Official title: Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Male infertility
In vitro fertilization
Intracytoplasmic sperm injection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: International Peace Maternity and Child Health Hospital
name: Women's Hospital School Of Medicine Zhejiang University
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: First Affiliated Hospital of Kunming Medical University
name: Beijing Haidian Maternal and Child Health Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: The Second Hospital of Hebei Medical University
name: The Third Affiliated Hospital of Guangzhou Medical University
name: General Hospital of Ningxia Medical University
First posted: 2017-10-02
Enrollment: 2387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients that have provided informed consent will be randomized to either ICSI or conventional IVF. Randomization and allocation of patients to study groups will be performed on the day of oocyte retrieval. Stratified permuted block randomization will be centrally controlled by administrative staffs in the trial center, who are not involved in the treatment procedure. When there is an eligible participant to be enrolled into the study, nurses from the specific site will login the trial system to get allocation of patients according to a computer-generated randomization list in a 1:1 ratio, with a variable block size of 2, 4 or 8 and stratified by center.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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%).

Primary outcomes:
measure: Ongoing pregnancy leading to live birth after the first cycle with embryo transfer
timeFrame: After 22 weeks of gestation
Secondary outcomes:
measure: Fertilization
timeFrame: 16-20 hours after oocyte retrieval
measure: Total fertilization failure
timeFrame: 72 hours after oocyte retrieval
measure: Available embryo
timeFrame: 72 hours after oocyte retrieval
measure: Good quality embryo
timeFrame: 72 hours after oocyte retrieval
measure: Implantation
timeFrame: 28 days after embryo transfer
measure: Clinical pregnancy
timeFrame: 7 weeks after embryo transfer
measure: Multiple pregnancy
timeFrame: 7 weeks after embryo transfer
measure: Ongoing pregnancy
timeFrame: 12 weeks after embryo transfer
measure: Moderate/severe ovarian hyperstimulation syndrome (OHSS)
timeFrame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.
measure: Miscarriage
timeFrame: 22 weeks of gestation
measure: Ectopic pregnancy
timeFrame: 7 weeks of gestation
measure: Gestational diabetes mellitus (GDM)
timeFrame: 24-37 weeks of pregnancy
measure: Hypertensive disorders of pregnancy
timeFrame: 28-37 weeks of pregnancy
measure: Antepartum haemorrhage
timeFrame: 28-37 weeks of pregnancy
measure: Preterm birth
timeFrame: 28-37 weeks of pregnancy
measure: Birth weight
timeFrame: Within 2 weeks after live birth
measure: Large for gestational age
timeFrame: Within 2 weeks after live birth
measure: Small for gestational age
timeFrame: Within 2 weeks after live birth
measure: Congenital anomaly
timeFrame: Within 2 weeks after live birth
measure: Perinatal mortality
timeFrame: Within 6 weeks after live birth
measure: Neonatal mortality
timeFrame: Within 6 weeks after live birth
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University third Hospital
state: Beijing
city: Beijing
country: China
facility: Haidian Maternal and Child Health Hospital
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Shanghai
country: China
facility: International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Women's Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao, M.D.
role: STUDY_DIRECTOR
References:
citation: Zheng D, Zeng L, Yang R, Lian Y, Zhu YM, Liang X, Tang L, Wang H, Cao Y, Hao G, Liu J, Zhao J, Wang R, Mol BW, Li R, Huang HF, Qiao J. Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial. BMJ Open. 2019 Sep 30;9(9):e030366. doi: 10.1136/bmjopen-2019-030366.