ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility (ICSI/IVF-NSMI)

July 25, 2023 updated by: Jie Qiao

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2387

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Rui Yang, M.D.
  • Phone Number: +86-010-82265080
  • Email: yrjeff@126.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Haidian Maternal and Child Health Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510150
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • The sixth affiliated hospital of Sun Yat-Sen University
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University
    • Yunnan
      • Kunming, Yunnan, China
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Women's Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intracytoplasmic Sperm Injection
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.
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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy leading to live birth after the first cycle with embryo transfer
Time Frame: After 22 weeks of gestation
A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).
After 22 weeks of gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fertilization
Time Frame: 16-20 hours after oocyte retrieval
Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).
16-20 hours after oocyte retrieval
Total fertilization failure
Time Frame: 72 hours after oocyte retrieval
No oocyte formed 2 PN in this given cycle.
72 hours after oocyte retrieval
Available embryo
Time Frame: 72 hours after oocyte retrieval
Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.
72 hours after oocyte retrieval
Good quality embryo
Time Frame: 72 hours after oocyte retrieval
Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation.
72 hours after oocyte retrieval
Implantation
Time Frame: 28 days after embryo transfer
Number of gestational sacs observed per embryo transferred.
28 days after embryo transfer
Clinical pregnancy
Time Frame: 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).
7 weeks after embryo transfer
Multiple pregnancy
Time Frame: 7 weeks after embryo transfer
Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.
7 weeks after embryo transfer
Ongoing pregnancy
Time Frame: 12 weeks after embryo transfer
Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
12 weeks after embryo transfer
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
Time Frame: 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.
From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.
Miscarriage
Time Frame: 22 weeks of gestation
Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.
22 weeks of gestation
Ectopic pregnancy
Time Frame: 7 weeks of gestation
Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
7 weeks of gestation
Gestational diabetes mellitus (GDM)
Time Frame: 24-37 weeks of pregnancy
24-37 weeks of pregnancy
Hypertensive disorders of pregnancy
Time Frame: 28-37 weeks of pregnancy
Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.
28-37 weeks of pregnancy
Antepartum haemorrhage
Time Frame: 28-37 weeks of pregnancy
Including placenta previa, placenta accreta and unexplained.
28-37 weeks of pregnancy
Preterm birth
Time Frame: 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.
28-37 weeks of pregnancy
Birth weight
Time Frame: 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).
Within 2 weeks after live birth
Large for gestational age
Time Frame: Within 2 weeks after live birth
Birth weight >90th centile for gestation, based on standardised ethnicity based charts.
Within 2 weeks after live birth
Small for gestational age
Time Frame: Within 2 weeks after live birth
Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Within 2 weeks after live birth
Congenital anomaly
Time Frame: Within 2 weeks after live birth
Any congenital anomaly will be included.
Within 2 weeks after live birth
Perinatal mortality
Time Frame: 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.
Within 6 weeks after live birth
Neonatal mortality
Time Frame: Within 6 weeks after live birth
death of a live born baby within 28 days of birth
Within 6 weeks after live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jie Qiao

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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
Sixth Affiliated Hospital, Sun Yat-sen University
General Hospital of Ningxia Medical University
Beijing Haidian Maternal and Child Health Hospital
International Peace Maternity and Child Health Hospital
First Affiliated Hospital of Kunming Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jie Qiao, M.D., Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICSI/IVF-NSMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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