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Trial record 21 of 370 for:    genital diseases AND (woman OR women OR female) AND live birth

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

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ClinicalTrials.gov Identifier: NCT03120884
Recruitment Status : Not yet recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
He-Feng Huang, International Peace Maternity and Child Health Hospital

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.


Condition or disease Intervention/treatment Phase
Infertility, Female ART Procedure: ICSI Procedure: IVF Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: IVF
embryos are cultured using conventional in vitro fertilization.A maximum of 2 embryos will be transferred for each treatment cycle.
Procedure: IVF
A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.
Other Name: in vitro fertilization

Experimental: ICSI
embryos are fertilized using ICSI.A maximum of 2 embryos will be transferred for each treatment cycle.
Procedure: ICSI
A technique that involves microinjection of spermatozoa into mature oocytes.
Other Name: Intracytoplasmic Sperm Injection




Primary Outcome Measures :
  1. accumulated live birth rate [ Time Frame: 42 weeks ]
    This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes


Secondary Outcome Measures :
  1. Fertilization rate [ Time Frame: 1 day after fertilization ]
    Fertilization rate was defined as the percentage of fetal heart beat among total retrieved oocytes

  2. Embryo quality [ Time Frame: 3day after fertilization ]
    Embryo quality was evaluated by microscopy.

  3. clinical pregnancy rate [ Time Frame: 35 days after embryo transfer ]
    Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.

  4. implantation rate [ Time Frame: 11-12 weeks after embryo transfer ]
    Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.

  5. biochemical pregnancy rate [ Time Frame: 2 weeks after embryo transfer ]
    Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.

  6. pregnancy loss rate [ Time Frame: 28 gestational weeks in maximum ]
    Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.

  7. ectopic pregnancy rate [ Time Frame: 12 gestational weeks in maximum ]
    Ectopic pregnancy is defined as an embryo implanted outside the uterine.



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Ages Eligible for Study:   38 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120884


Contacts
Contact: He-Feng Huang, MD +86-21-18017310186 hefenghuang@126.com

Locations
China, Shanghai
International Peace Maternity & Child Health Hospital Not yet recruiting
Shanghai, Shanghai, China, 200030
Contact: He-Feng Huang, MD    +86-21-18017310186    hefenghuang@126.com   
Sponsors and Collaborators
International Peace Maternity and Child Health Hospital
Investigators
Principal Investigator: He-Feng Huang, MD Shanghai Jiao Tong University School of Medicine

Responsible Party: He-Feng Huang, President, International Peace Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT03120884     History of Changes
Other Study ID Numbers: IPMCH2017001
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female