NCT03298633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,387

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

September 22, 2017

Last Update Submit

July 25, 2023

Conditions

Male Infertility

Keywords

Male infertilityIn vitro fertilizationIntracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Fertilization

    16-20 hours after oocyte retrieval

  • Total fertilization failure

    72 hours after oocyte retrieval

  • Available embryo

    72 hours after oocyte retrieval

  • Good quality embryo

    72 hours after oocyte retrieval

  • Implantation

    28 days after embryo transfer

  • +16 more secondary outcomes

Study Arms (2)

Intracytoplasmic Sperm Injection

ACTIVE COMPARATOR

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

Conventional IVF

ACTIVE COMPARATOR

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

Interventions

ICSIOTHER

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.

Intracytoplasmic Sperm Injection
Conventional IVFOTHER

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.

Conventional IVF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Peking University third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Haidian Maternal and Child Health Hospital

Beijing, Beijing Municipality, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Women's Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (2)

  • Wang Y, Li R, Yang R, Zheng D, Zeng L, Lian Y, Zhu Y, Zhao J, Liang X, Li W, Liu J, Tang L, Cao Y, Hao G, Wang H, Zhang H, Wang R, Mol BW, Huang H, Qiao J. Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial. Lancet. 2024 Mar 9;403(10430):924-934. doi: 10.1016/S0140-6736(23)02416-9. Epub 2024 Feb 5.

    PMID: 38330980DERIVED

  • 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.

    PMID: 31575574DERIVED

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Jie Qiao, M.D.

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The blinding method in out study is open-label in general. However, in order to avoid psychological effect for participants and unexpected drop-off, the trial is designed to inform participants their insemination method on the day of fresh embryo transfer or the day of embryo freezing. Prior to this, randomization will be strictly performed and keep secret to participants and clinicians.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 2, 2017

Study Start

April 4, 2018

Primary Completion

January 31, 2023

Study Completion

March 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)