At a glance

ClinicalIndex Comparison Record

N/ACompleted· 2,387 enrolled

Drug / intervention

ICSI +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03298633

NCT03298633N/ACompleted

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

Jie Qiao·interventional·Posted Oct 2, 2017·Updated Jul 27, 2023

In Brief

A clinical study evaluating ICSI and Conventional IVF for Male Infertility. Completed, enrolled 2,387 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMale Infertility

CountriesChina

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

Timeline

N/ACompletedFinished

201820192020202120222023202420252026

First PostedOct 2017

Enrollment StartApr 2018

Primary CompletionJan 2023

Study CompletionMar 2023

TodayJul 2026

First PostedOct 2, 2017

Enrollment StartApr 4, 2018

Primary CompletionJan 31, 2023

Study CompletionMar 31, 2023

TodayJul 2, 2026

Enrollment to primary: 4.8 yearsPosted 8.8 years ago

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.

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.