ICSI Versus Conventional IVF in Couples With Unexplained Infertility

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).

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.

Number of oocyte obtained on the day of oocyte retrieval

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

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

The proportion of fertilized oocytes to the total number of retrieved oocytes.

Normal fertilization is defined as the appearance of 2PN

Abnormal fertilization is defined as the appearance of 1PN or ≥3PN

[Only in ICSI group] The proportion of oocytes that undergo degeneration assessed on Day 2 among all oocytes receiving ICSI.

The proportion of normal cleavage observed on Day 2 in normally fertilized oocytes

The proportion of 4-cell stage embryos formed on Day 2 compared to normal fertilized oocytes.

The proportion of 8-cell stage embryos formed on Day 3 compared to normal fertilized oocytes.

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.

The proportion of the number of blastocysts formed to the number of embryos undergoing blastocyst culture.

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.

The proportion of good quality blastocysts to the total number of blastocysts.

Number of blastocysts of BC, CB grade and above, according to the Gardner scoring system.

The total number of embryos that can be utilized for transplantation or cryopreservation.

Total fertilisation failure rate is defined as the absence of any zygotes with 2PN

The proportion of cycles with total fertilization failure or no available embryo to all oocyte retrieval cycles.

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.

Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 10mIU/mL after embryo transfer.

Clinical pregnancy is defined as ultrasound detection of at least one gestational sac or other clear pregnancy manifestations under ultrasound (including clear ectopic pregnancy).

Implantation rate is defined as the number of gestational sacs per number of embryos transferred.

Ongoing pregnancy refers to the presence of a gestational sac and fetal heart beat after 12 weeks of gestation.

Ectopic pregnancy is defined as the presence of the gestational sac outside the uterine cavity detected by ultrasound.

Multiple pregnancy is defined as the detection of two or more gestational sacs or positive heart beats by ultrasound.

Miscarriage refers to the loss of an intra-uterine pregnancy before 24 weeks of gestation.

Abnormal OGTT test

The hypertensive disorders of pregnancy include gestational hypertension, chronic hypertension, pre-eclampsia, chronic hypertension with preeclampsia, eclampsia and HELLP syndrome.

Vaginal bleeding caused by placenta previa, placental implantation, or unknown reasons in mid or late pregnancy.

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.

Pregnancy terminates after 28 weeks and before 37 weeks of gestation.

Termination of pregnancy due to premature rupture of membranes or spontaneous uterine contractions between 28 to 37 weeks of gestation.

Termination of pregnancy due to iatrogenic factors between 28 to 37 weeks of gestation.

Weight of newborn, classified as very low birth weight (<1500g), low birth weight (1500-2500g), macrosomia (>4000g).

Birth weight below the 10th percentile for gestational age.

Birth weight above the 90th percentile for gestational age.

Any birth defect or congenital anomaly will be included.

The admittance of the newborn to NICU.

Fetal or neonatal death occurring after 28 weeks of gestation, during delivery, or within 7 days after birth.

Death of a live born baby within 28 days of birth.