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

NCT03120884 | Unknown DMC

• 1 other identifier: IPMCH2017001
• Study Type: interventional
• Target: 1,422
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• accumulated live birth rate

  This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes

  42 weeks

Secondary Outcomes (7)

• Fertilization rate

  1 day after fertilization

• Embryo quality

  3day after fertilization

• clinical pregnancy rate

  35 days after embryo transfer

• implantation rate

  11-12 weeks after embryo transfer

• biochemical pregnancy rate

  2 weeks after embryo transfer

Study Arms (2)

IVF

EXPERIMENTAL

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

Procedure: IVF

ICSI

EXPERIMENTAL

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

Procedure: ICSI

Interventions

ICSI PROCEDURE

A technique that involves microinjection of spermatozoa into mature oocytes.

Also known as: Intracytoplasmic Sperm Injection

ICSI

IVF PROCEDURE

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

Also known as: in vitro fertilization

IVF

Eligibility Criteria

• Age: 38 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

International Peace Maternity & Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Sperm Injections, Intracytoplasmic; Fertilization in Vitro

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• He-Feng Huang, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He-Feng Huang, MD

CONTACT

+86-21-18017310186; hefenghuang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 19, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

CN (1)