Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age

NCT ID: NCT03120884

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-09-01

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.

Conditions

Infertility, Female; ART

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVF

embryos are cultured using conventional in vitro fertilization.A maximum of 2 embryos will be transferred for each treatment cycle.

Group Type: EXPERIMENTAL

IVF

Intervention Type: PROCEDURE

A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.

ICSI

embryos are fertilized using ICSI.A maximum of 2 embryos will be transferred for each treatment cycle.

Group Type: EXPERIMENTAL

ICSI

Intervention Type: PROCEDURE

A technique that involves microinjection of spermatozoa into mature oocytes.

Interventions

ICSI

A technique that involves microinjection of spermatozoa into mature oocytes.

Intervention Type: PROCEDURE

IVF

A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.

Intervention Type: PROCEDURE

Other Intervention Names

Intracytoplasmic Sperm Injection; in vitro fertilization

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.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role: lead

Responsible Party

He-Feng Huang

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He-Feng Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

International Peace Maternity & Child Health Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

He-Feng Huang, MD

Role: CONTACT

hefenghuang@126.com

+86-21-18017310186

Facility Contacts

He-Feng Huang, MD

Role: primary

hefenghuang@126.com

+86-21-18017310186

Other Identifiers

IPMCH2017001

Identifier Type: -

Identifier Source: org_study_id