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ClinicalTrials.gov ID

NCT07294027

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

848Estimated

Last Update Posted

Dec 19, 2025Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Jul 30, 2028Estimated

Completion Date

Jul 30, 2028Estimated

Official Title

Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial

Brief Summary

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.

Detailed 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.

• Unexplained Infertility

• ICSI
• IVF

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Collaborators

Renmin Hospital of Wuhan UniversityOTHER

Jiaxing Maternity and Child Health Care HospitalOTHER

Ningbo Women & Children's HospitalOTHER

Beijing Obstetrics and Gynecology HospitalOTHER

Xiangyang Central HospitalOTHER

Huangshi Central HospitalOTHER

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