Infertility
Conditions
Keywords
ICSI outcome
Brief summary
Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS
Detailed description
A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit, International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar University. Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS (female age, number of retrieved oocytes, number of EC embryos, number of good quality embryos and number of embryos transferred).
Interventions
OTHEREdessy ICSI Outcome Embryo Score
EIOS: Age (ys) \>35 (0) 30-35 (1) \<30 (2) No of retrived oocyte \<5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos \<2 (0) 2-4 (1) \>4 (2) No of good quality embryos \<3 (0) 3-5 (1) \>5 (2) No of embryos transferred -------- (0) ≤2 (1) \>2 (2)
Sponsors
Al-Azhar University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age ≤ 40 years old. BMI \>25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol
Exclusion criteria
uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...). azoospermia as a cause of male factor infertility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy | 6 weeks | A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edessy ICSI Outcome Embryo Score Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) \>35 (0) 30-35 (1) \<30 (2) No of retrived oocyte \<5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos \<2 (0) 2-4 (1) \>4 (2) No of good quality embryos \<3 (0) 3-5 (1) \>5 (2) No of embryos transferred -------- (0) ≤2 (1) \>2 (2) | 243 |
| Total | 243 |
Baseline characteristics
| Characteristic | Edessy ICSI Outcome Embryo Score |
|---|---|
| Age, Continuous | 30.12 years STANDARD_DEVIATION 3.51 |
| Sex: Female, Male Female | 243 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Clinical Pregnancy
A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edessy ICSI Outcome Embryo Score | Clinical Pregnancy | 71 participants |