Clinical trial NCT03120884: Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
Official title: Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
ART
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 1422
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.

The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.

The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.


Eligibility criteria: Inclusion Criteria:

* Female patients ages ≥38 years old with FSH ≤15;
* Spouse with normal sperm analysis according to WHO fifth edition criteria(sperm parameter values: total sperm count of at least 39 million, concentration≥15 × 106/ml, total motility ≥40%, progressive motility ≥32%， strict morphology ≥4% normal forms)；
* Female patients who intended to undergo IVF and had signed a written consent form.

Exclusion Criteria:

* More than three previous IVF cycles (including both failed cycles and cycles that ended in live births)
* Female patients with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility; Female patients who have previously been diagnosed with a uterine abnormality such as a malformed uterus(uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;
* Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;
* Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region
* the use of donor oocytes or sperm;
* the use of frozen oocytes or sperm;
* Femal patients with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding;
* Spouse with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease;
* Female patients or their partners who are unable to comply with the study Procedures;
* Female patients who had previously been randomized to either of the two study groups in this trial.

Primary outcomes:
measure: accumulated live birth rate
timeFrame: 42 weeks
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day after fertilization
measure: Embryo quality
timeFrame: 3day after fertilization
measure: clinical pregnancy rate
timeFrame: 35 days after embryo transfer
measure: implantation rate
timeFrame: 11-12 weeks after embryo transfer
measure: biochemical pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: pregnancy loss rate
timeFrame: 28 gestational weeks in maximum
measure: ectopic pregnancy rate
timeFrame: 12 gestational weeks in maximum
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity & Child Health Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: He-Feng Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: