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ICSI Versus Conventional IVF in Couples With Unexplained Infertility

ConditionUnexplained Infertility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-38
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 20-38 years

18.5 < BMI < 24kg/m2

Regular menses or confirmed ovulation;

Normal ovarian reserve;

Disqualifiers

Preimplantation genetic testing (PGT) cycles

In vitro maturation (IVM) cycles

Using donor sperm/oocyte

Using frozen sperm/oocyte

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICSI

    Procedure/Surgery

    Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection. Other standard assisted reproductive treatments are similar and parallel between two groups.

  • IVF

    Procedure/Surgery

    Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm/ml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination. If the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The injection method is same as standard ICSI. Other standard assisted reproductive treatments are similar and parallel between two groups.

Treatment groups

848 Participants
are divided into 2 treatment groups
Group A: Intracytoplasmic Sperm Injection (ICSI)Active comparator 1 intervention
Group B: Conventional in vitro fertilization (c-IVF)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth rate after the first embryo transfer cycle

Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count).

Time frame
At birth

Secondary outcomes

1

Cumulative ongoing pregnancy rate within one year

Achieving ongoing pregnancy within 12 months after randomization, regardless of the number of embryo transfers performed (limited to embryos obtained in the current study). Ongoing pregnancy refers to the presence of a gestational sac and fetal heart beat after 12 weeks of gestation.

Time frame
At 12 weeks of gestation; At 12 months after randomization
2

Number of retrieved oocyte

Number of oocyte obtained on the day of oocyte retrieval

Time frame
2 hours after oocyte retrieval
3

MII rate

\[Only in ICSI group\] The proportion of MII oocytes to the total number of retrieved oocytes.

Time frame
2 hours after oocyte retrieval
4

Fertilization rate per oocyte inseminated/injected

The proportion of fertilized oocytes to inseminated oocytes (IVF group) / injected oocytes (ICSI group).

Time frame
At 16-18 hours after insemination or injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Renmin Hospital of Wuhan University

Collaborator

Jiaxing Maternity and Child Health Care Hospital

Collaborator

Ningbo Women & Children's Hospital

Collaborator

Beijing Obstetrics and Gynecology Hospital

Collaborator

Xiangyang Central Hospital

Collaborator

Huangshi Central Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: