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Trial record 29 of 398 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

Preimplantation Genetic Screening in Patients With Male Factor Infertility

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ClinicalTrials.gov Identifier: NCT02941965
Recruitment Status : Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : March 15, 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 patients with male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 650 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (325 cases), Group B will undergo ICSI with PGS (690 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.

The target population will be patients with male-factor infertility aged between 20 and 50 years, diagnosed by the ESHER Criteria (oligospermia and asthenspermia). Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.

The randomization will take place before the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.


Condition or disease Intervention/treatment Phase
Infertility, Male Diagnosis, Preimplantation Procedure: ICSI without PGS Procedure: ICSI with PGS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preimplantation Genetic Screening in Patients With Male Factor Infertility
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: ICSI without PGS
Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.
Procedure: ICSI without PGS
Selection of embryos are based on morphology criteria on the 5th day of ICSI.

Experimental: ICSI with PGS

PGS will be applied to select embryos on day 5, only euploid embryos will be transferred.

A maximum of 2 embryos will be transferred for each treatment cycle.

Procedure: ICSI with PGS
PGS will be applied to selected embryos on the 5th day of ICSI.




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


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

  2. 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.

  3. 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.

  4. 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.

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

  6. Congenital Anomalies rate [ Time Frame: 1 day after delivery ]
    Congenital anomaly included deformity and development abnormality of any organs or systems.

  7. neonatal complication rate [ Time Frame: 1 day after delivery ]
    Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patients ages between 20 to 50 years old;
  2. Male patients diagnosed with oligospermia or asthenospermia according to the ESHER criteria;
  3. Male patients who intended to undergo ICSI and had signed a written consent form.

Exclusion Criteria:

  1. Male patients with azoospermia, sexual dysfunction, immunological infertility;
  2. Spouse with advanced age(>35 years old);
  3. Spouse 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;
  4. Spouse with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility;
  5. Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;
  6. Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region
  7. 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; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding;
  8. Male 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;
  9. Male patients or their partners who are unable to comply with the study Procedures;
  10. Male 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): NCT02941965


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 Shanghai Jiao Tong University School of Medicine

Responsible Party: He-Feng Huang, President, International Peace Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT02941965     History of Changes
Other Study ID Numbers: IPMCH2016001
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: October 2016
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, Male
Genital Diseases, Male
Genital Diseases, Female