ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility

Male Infertility Clinical Trial

— ICSI/IVF-NSMI  

Official title:

Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298633
• Other study ID #: ICSI/IVF-NSMI
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2387
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Other:
• ICSI
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.
• Conventional IVF
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.

Locations

Country	Name	City	State
China	Haidian Maternal and Child Health Hospital	Beijing	Beijing
China	Peking University third Hospital	Beijing	Beijing
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Women's Hospital of Zhejiang University	Hangzhou	Zhejiang
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (10)

Lead Sponsor

Collaborator

Jie Qiao

Beijing Haidian Maternal and Child Health Hospital, First Affiliated Hospital of Kunming Medical University, General Hospital of Ningxia Medical University, International Peace Maternity and Child Health Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Hebei Medical University, The Third Affiliated Hospital of Guangzhou Medical University, Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	After 22 weeks of gestation
Secondary	Fertilization	Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).	16-20 hours after oocyte retrieval
Secondary	Total fertilization failure	No oocyte formed 2 PN in this given cycle.	72 hours after oocyte retrieval
Secondary	Available embryo	Number of embryos =4 cells and =30% fragmentation on day 3 observation.	72 hours after oocyte retrieval
Secondary	Good quality embryo	Number of embryos with =6 cells and =30% fragmentation developed from 2PN embryos on day 3 observation.	72 hours after oocyte retrieval
Secondary	Implantation	Number of gestational sacs observed per embryo transferred.	28 days after embryo transfer
Secondary	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).	7 weeks after embryo transfer
Secondary	Multiple pregnancy	Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.	7 weeks after embryo transfer
Secondary	Ongoing pregnancy	Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.	12 weeks after embryo transfer
Secondary	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.	From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.
Secondary	Miscarriage	Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.	22 weeks of gestation
Secondary	Ectopic pregnancy	Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.	7 weeks of gestation
Secondary	Gestational diabetes mellitus (GDM)		24-37 weeks of pregnancy
Secondary	Hypertensive disorders of pregnancy	Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.	28-37 weeks of pregnancy
Secondary	Antepartum haemorrhage	Including placenta previa, placenta accreta and unexplained.	28-37 weeks of pregnancy
Secondary	Preterm birth	Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.	28-37 weeks of pregnancy
Secondary	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).	Within 2 weeks after live birth
Secondary	Large for gestational age	Birth weight >90th centile for gestation, based on standardised ethnicity based charts.	Within 2 weeks after live birth
Secondary	Small for gestational age	Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.	Within 2 weeks after live birth
Secondary	Congenital anomaly	Any congenital anomaly will be included.	Within 2 weeks after live birth
Secondary	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.	Within 6 weeks after live birth
Secondary	Neonatal mortality	death of a live born baby within 28 days of birth	Within 6 weeks after live birth