ICSI Versus Conventional IVF in Couples With Unexplained Infertility (ICSI/IVF-UI)

Zhejiang University

Status: Not yet enrolling

Conditions: Unexplained Infertility

Treatments: Procedure: IVF; Procedure: ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT07294027

2025-0689

Details and patient eligibility

About

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.

Full description

A multicenter, large-scale, randomized controlled clinical trial will enroll 848 couples with unexplained infertility undergoing their first 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 1 years with a total of 9 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to either the ICSI group or the IVF group in a 1:1 ratio. All participants will be randomized through block randomization, and each center will enroll participants using a competitive enrollment method.

Enrollment: 848 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 20-38 years

2. 18.5 < BMI < 24kg/m2

3. Couples diagnosed with primary unexplained infertility:

   • Regular menses or confirmed ovulation;

     • Normal ovarian reserve;

       • Patent fallopian tubes;

         • Normal uterus and cervix;

           • Normal endocrine profile;

             • Semen analysis meeting WHO 6th edition criteria

               • Normal karyotypes in both partners, no family history of genetic disorders

4. First IVF/ICSI cycle

5. Received GnRH agonist protocol or GnRH antagonist protocol

6. Willing to provide informed consent and comply with follow-up

Exclusion criteria

1. Preimplantation genetic testing (PGT) cycles
2. In vitro maturation (IVM) cycles
3. Using donor sperm/oocyte
4. Using frozen sperm/oocyte
5. <5 oocytes retrieved
6. Abnormal semen parameters on the day of oocyte retrieval
7. High risk of tubal pathology or endometriosis without laparoscopic exclusion
8. Untreated or poorly controlled endocrine disorders
9. Abnormal immune related examinations
10. Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)
11. Concurrent participation in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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848 participants in 2 patient groups

Intracytoplasmic Sperm Injection (ICSI)

Active Comparator group

Description:

All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo ICSI procedure according to the result of randomization. The first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. The remaining available embryos will be frozen.

Treatment:

Procedure: ICSI

Conventional in vitro fertilization (c-IVF)

Active Comparator group

Description:

All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo conventional IVF procedure according to the result of randomization. The first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. If the embryos in the IVF group are fertilized through different methods (some with late-RICSI), the first embryo transfer is limited to embryos fertilized through conventional IVF. The remaining available embryos will be frozen.

Treatment:

Procedure: IVF