Unexplained InfertilityICSI/IVF-UINCT07294027
ICSI Versus Conventional IVF in Couples With Unexplained Infertility
A study testing ICSI and IVF in people with Unexplained Infertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- ICSI and IVF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jan 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20-38 years
- 18.5 < BMI < 24kg/m2
- Couples diagnosed with primary unexplained infertility:
- Regular menses or confirmed ovulation;
- Normal ovarian reserve;
- Patent fallopian tubes;
Show all 13Show fewer
- 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
- First IVF/ICSI cycle
- Received GnRH agonist protocol or GnRH antagonist protocol
- Willing to provide informed consent and comply with follow-up
Who cannot join
- Preimplantation genetic testing (PGT) cycles
- In vitro maturation (IVM) cycles
- Using donor sperm/oocyte
- Using frozen sperm/oocyte
- <5 oocytes retrieved
- Abnormal semen parameters on the day of oocyte retrieval
Show all 11Show fewer
- High risk of tubal pathology or endometriosis without laparoscopic exclusion
- Untreated or poorly controlled endocrine disorders
- Abnormal immune related examinations
- Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)
- Concurrent participation in other clinical trials.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality
Xiaokui Yang, +86-010-52276699, yangxiaokui@ccmu.edu.cn
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310052
Min Jin, +86-15925602121, min_jin@zju.edu.cn
Huangshi Central Hospital
Huangshi, Hubei, 435000
Junling Wang, +86-0714-3189999, wangjunling225969@163.com
Jiaxing Maternity and Child Health Care Hospital
Jiaxing, Zhejiang, 314051
Weiping Fu, +86-0573-82066132, fuweiping2816@163.com
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, 315012
Liming Zhou, +86-0574-87083300, zhou.li.ming@163.com
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Qingzhen Xie, +86-027-88041911, rm001138@whu.edu.cn
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Xuezhou Yang, +86-0710-3520081, dryangxz@163.com
About this study
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
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.
Read the 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.
- Conditions
- Unexplained Infertility
- Being tested
- ICSI, IVF
- Keywords
- Unexplained infertility, Conventional in vitro fertilization, Intracytoplasmic sperm injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or 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.
IVFProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Intracytoplasmic Sperm Injection (ICSI) | Active comparator | 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. Receives: Procedure: ICSI |
| Conventional in vitro fertilization (c-IVF) | Active comparator | 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. Receives: Procedure: IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At birth
Secondary outcomes (42)
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.
Measured: At 12 weeks of gestation; At 12 months after randomization
Number of retrieved oocyte
Number of oocyte obtained on the day of oocyte retrieval
Measured: 2 hours after oocyte retrieval
MII rate
[Only in ICSI group] The proportion of MII oocytes to the total number of retrieved oocytes.
Measured: 2 hours after oocyte retrieval
Fertilization rate per oocyte inseminated/injected
The proportion of fertilized oocytes to inseminated oocytes (IVF group) / injected oocytes (ICSI group).
Measured: At 16-18 hours after insemination or injection
Fertilization rate per oocyte retrieved
The proportion of fertilized oocytes to the total number of retrieved oocytes.
Measured: At 16-18 hours after insemination or injection
Normal fertilization rate
Normal fertilization is defined as the appearance of 2PN
Measured: At 16-18 hours after insemination or injection
Abnormal fertilization rate
Abnormal fertilization is defined as the appearance of 1PN or ≥3PN
Measured: At 16-18 hours after insemination or injection
Degeneration rate of ICSI oocytes
[Only in ICSI group] The proportion of oocytes that undergo degeneration assessed on Day 2 among all oocytes receiving ICSI.
Measured: At 16-18 hours after injection
Cleavage rate
The proportion of normal cleavage observed on Day 2 in normally fertilized oocytes
Measured: At 16-18 hours after insemination or injection
Day 2 embryo formation rate
The proportion of 4-cell stage embryos formed on Day 2 compared to normal fertilized oocytes.
Measured: 2 days after oocyte retrieval
Day 3 embryo formation rate
The proportion of 8-cell stage embryos formed on Day 3 compared to normal fertilized oocytes.
Measured: 3 days after oocyte retrieval
Good quality embryo rate on Day 3
The proportion of I-II grade embryos with 6-10 cells on Day 3 compared to normal fertilized oocytes, according to Peter's scoring criteria.
Measured: 3 days after oocyte retrieval
Blastocyst formation rate
The proportion of the number of blastocysts formed to the number of embryos undergoing blastocyst culture.
Measured: 6 days after oocyte retrieval
Good quality blastocyst formation rate
The proportion of the number of blastocysts classified as 3BB or higher grade (according to Gardner scoring system) to the number of embryos undergoing blastocyst culture.
Measured: 6 days after oocyte retrieval
Good quality blastocyst rate
The proportion of good quality blastocysts to the total number of blastocysts.
Measured: 6 days after oocyte retrieval
Number of available blastocyst
Number of blastocysts of BC, CB grade and above, according to the Gardner scoring system.
Measured: 6 days after oocyte retrieval
Number of available embryo
The total number of embryos that can be utilized for transplantation or cryopreservation.
Measured: 6 days after oocyte retrieval
Total fertilization failure rate
Total fertilisation failure rate is defined as the absence of any zygotes with 2PN
Measured: At 16-18 hours after insemination or injection
Cycle cancellation rate
The proportion of cycles with total fertilization failure or no available embryo to all oocyte retrieval cycles.
Measured: 6 days after oocyte retrieval
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
The exaggerated systemic response to ovarian stimulation. It is classified into mild, moderate, and severe based on the degree of bloating, ovarian volume enlargement, and respiratory, hemodynamic, and metabolic complications.
Measured: At 10days after trigger; At 14 days after embryo transfer
Positive pregnancy rate
Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 10mIU/mL after embryo transfer.
Measured: 10-14 days after embryo transfer; At 12 months after randomization
Clinical pregnancy rate
Clinical pregnancy is defined as ultrasound detection of at least one gestational sac or other clear pregnancy manifestations under ultrasound (including clear ectopic pregnancy).
Measured: 30 days after embryo transfer
Implantation rate
Implantation rate is defined as the number of gestational sacs per number of embryos transferred.
Measured: 30 days after embryo transfer; At 12 months after randomization
Ongoing pregnancy rate
Ongoing pregnancy refers to the presence of a gestational sac and fetal heart beat after 12 weeks of gestation.
Measured: At 12 weeks of gestation; At 12 months after randomization
Ectopic pregnancy
Ectopic pregnancy is defined as the presence of the gestational sac outside the uterine cavity detected by ultrasound.
Measured: 30 days after embryo transfer; At 12 months after randomization
Multiple pregnancy rate
Multiple pregnancy is defined as the detection of two or more gestational sacs or positive heart beats by ultrasound.
Measured: 30 days after oocyte retrieval; At 12 months after randomization
Miscarriage rate
Miscarriage refers to the loss of an intra-uterine pregnancy before 24 weeks of gestation.
Measured: At 24 weeks of gestation; At 12 months after randomization
Gestational diabetes mellitus
Abnormal OGTT test
Measured: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy
The hypertensive disorders of pregnancy include gestational hypertension, chronic hypertension, pre-eclampsia, chronic hypertension with preeclampsia, eclampsia and HELLP syndrome.
Measured: From 20 weeks of gestation up to at birth
Antepartum haemorrhage
Vaginal bleeding caused by placenta previa, placental implantation, or unknown reasons in mid or late pregnancy.
Measured: From 20 weeks of gestation up to at birth
Thrombotic diseases
If the participant experiences clinical symptoms such as lower limb pain, chest pain, hemoptysis, etc., and there is a high suspicion of thrombotic disease in clinical practice, confirmation will be made through examinations such as vascular ultrasound and CT angiography.
Measured: From 20 weeks of gestation up to 4-6 weeks after birth
Gestational age at delivery
Measured: At birth
Preterm birth
Pregnancy terminates after 28 weeks and before 37 weeks of gestation.
Measured: At birth
Spontaneous preterm birth
Termination of pregnancy due to premature rupture of membranes or spontaneous uterine contractions between 28 to 37 weeks of gestation.
Measured: At birth
Iatrogenic preterm birth
Termination of pregnancy due to iatrogenic factors between 28 to 37 weeks of gestation.
Measured: At birth
Birth weight
Weight of newborn, classified as very low birth weight (<1500g), low birth weight (1500-2500g), macrosomia (>4000g).
Measured: At birth
Small for gestational age
Birth weight below the 10th percentile for gestational age.
Measured: At birth
Large for gestational age
Birth weight above the 90th percentile for gestational age.
Measured: At birth
Birth defect / Congenital anomaly
Any birth defect or congenital anomaly will be included.
Measured: At birth; At 4-6 weeks after birth
NICU admission
The admittance of the newborn to NICU.
Measured: At 4-6 weeks after birth
Perinatal mortality
Fetal or neonatal death occurring after 28 weeks of gestation, during delivery, or within 7 days after birth.
Measured: At 4-6 weeks after birth
Neonatal mortality
Death of a live born baby within 28 days of birth.
Measured: At 4-6 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter study. Each center enrolls participants using a competitive enrollment method and performs online randomization through the trial system. Using block randomization with a 1:1 allocation ratio, participants were assigned to either the ICSI group or the IVF group, with a block length set at 8. The trial system administrators were not involved in the treatment process. Eligible patients who provided informed consent were registered in the trial system by medical staff at each center on the day of oocyte retrieval. After entering participant information, the system automatically assigned patients based on pre-set parameters.
- Masking
- None (open label)
- Enrolment
- 848 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Jiaxing Maternity and Child Health Care Hospital, Ningbo Women & Children's Hospital, Beijing Obstetrics and Gynecology Hospital, Xiangyang Central Hospital, Huangshi Central Hospital
- Responsible party
- Sponsor
- Investigators
- Min Jin, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294027
- Sponsor's protocol ID
- 2025-0689
- Acronym
- ICSI/IVF-UI
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07294027
- Acronym / sponsor ID
- ICSI/IVF-UI / 2025-0689
- Conditions
- Unexplained Infertility
- Keywords
- Unexplained infertility, Conventional in vitro fertilization, Intracytoplasmic sperm injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 848 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Jiaxing Maternity and Child Health Care Hospital, Ningbo Women & Children's Hospital, Beijing Obstetrics and Gynecology Hospital, Xiangyang Central Hospital, Huangshi Central Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter study. Each center enrolls participants using a competitive enrollment method and performs online randomization through the trial system. Using block randomization with a 1:1 allocation ratio, participants were assigned to either the ICSI group or the IVF group, with a block length set at 8. The trial system administrators were not involved in the treatment process. Eligible patients who provided informed consent were registered in the trial system by medical staff at each center on the day of oocyte retrieval. After entering participant information, the system automatically assigned patients based on pre-set parameters.
| Arm | Type | Receives |
|---|---|---|
| Intracytoplasmic Sperm Injection (ICSI) | Active comparator | Procedure: ICSIAll 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. |
| Conventional in vitro fertilization (c-IVF) | Active comparator | Procedure: IVFAll 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. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Aged 20-38 years
- 18.5 < BMI < 24kg/m2
- Couples diagnosed with primary unexplained infertility:
- First IVF/ICSI cycle
- Received GnRH agonist protocol or GnRH antagonist protocol
Key exclusion criteria (11 listed)
- Preimplantation genetic testing (PGT) cycles
- In vitro maturation (IVM) cycles
- Using donor sperm/oocyte
- Using frozen sperm/oocyte
- <5 oocytes retrieved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICSIInsemination 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. | Procedure or surgery | Intracytoplasmic Sperm Injection (ICSI) |
| IVFInsemination 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. | Procedure or surgery | Conventional in vitro fertilization (c-IVF) |
Primary outcome
Live birth rate after the first embryo transfer cycle
Time frame: At birth
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).
42 secondary outcomes
Cumulative ongoing pregnancy rate within one year
Time frame: At 12 weeks of gestation; At 12 months after randomization
Number of retrieved oocyte
Time frame: 2 hours after oocyte retrieval
MII rate
Time frame: 2 hours after oocyte retrieval
Fertilization rate per oocyte inseminated/injected
Time frame: At 16-18 hours after insemination or injection
Fertilization rate per oocyte retrieved
Time frame: At 16-18 hours after insemination or injection
Normal fertilization rate
Time frame: At 16-18 hours after insemination or injection
Abnormal fertilization rate
Time frame: At 16-18 hours after insemination or injection
Degeneration rate of ICSI oocytes
Time frame: At 16-18 hours after injection
Cleavage rate
Time frame: At 16-18 hours after insemination or injection
Day 2 embryo formation rate
Time frame: 2 days after oocyte retrieval
Day 3 embryo formation rate
Time frame: 3 days after oocyte retrieval
Good quality embryo rate on Day 3
Time frame: 3 days after oocyte retrieval
Blastocyst formation rate
Time frame: 6 days after oocyte retrieval
Good quality blastocyst formation rate
Time frame: 6 days after oocyte retrieval
Good quality blastocyst rate
Time frame: 6 days after oocyte retrieval
Number of available blastocyst
Time frame: 6 days after oocyte retrieval
Number of available embryo
Time frame: 6 days after oocyte retrieval
Total fertilization failure rate
Time frame: At 16-18 hours after insemination or injection
Cycle cancellation rate
Time frame: 6 days after oocyte retrieval
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
Time frame: At 10days after trigger; At 14 days after embryo transfer
Positive pregnancy rate
Time frame: 10-14 days after embryo transfer; At 12 months after randomization
Clinical pregnancy rate
Time frame: 30 days after embryo transfer
Implantation rate
Time frame: 30 days after embryo transfer; At 12 months after randomization
Ongoing pregnancy rate
Time frame: At 12 weeks of gestation; At 12 months after randomization
Ectopic pregnancy
Time frame: 30 days after embryo transfer; At 12 months after randomization
Multiple pregnancy rate
Time frame: 30 days after oocyte retrieval; At 12 months after randomization
Miscarriage rate
Time frame: At 24 weeks of gestation; At 12 months after randomization
Gestational diabetes mellitus
Time frame: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy
Time frame: From 20 weeks of gestation up to at birth
Antepartum haemorrhage
Time frame: From 20 weeks of gestation up to at birth
Thrombotic diseases
Time frame: From 20 weeks of gestation up to 4-6 weeks after birth
Gestational age at delivery
Time frame: At birth
Preterm birth
Time frame: At birth
Spontaneous preterm birth
Time frame: At birth
Iatrogenic preterm birth
Time frame: At birth
Birth weight
Time frame: At birth
Small for gestational age
Time frame: At birth
Large for gestational age
Time frame: At birth
Birth defect / Congenital anomaly
Time frame: At birth; At 4-6 weeks after birth
NICU admission
Time frame: At 4-6 weeks after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Unexplained Infertility
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruitingPhase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
Leiomyoma, Uterine
Recruiting
Royal Jelly Supplementation in Unexplained Male Infertility
Unexplained Infertility, Male Infertility
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Jin, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI and IVF in people with Unexplained Infertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Jin, PhD (+86-15925602121, min_jin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate after the first embryo transfer cycle (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.