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

NCT03120884 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1422

Last updated 2017-04-19

No results posted yet for this study

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

Interventions

PROCEDURE

ICSI

A technique that involves microinjection of spermatozoa into mature oocytes.

PROCEDURE

IVF

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

Sponsors & Collaborators

  • International Peace Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • He-Feng Huang, MD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-09-01
Completion
2019-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120884 on ClinicalTrials.gov