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Preimplantation Genetic Screening in Patients With Male Factor Infertility

Preimplantation Genetic Screening in Patients With Male Factor Infertility: a randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16009500
Enrollment
Unknown
Registered
2016-10-20
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male factor infertility

Interventions

PGS+ICSI:PGS
ICSI:ICSI

Sponsors

International Peace Maternity & Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Male patients aged 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

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.

Design outcomes

Primary

MeasureTime frame
live birth rate;

Secondary

MeasureTime frame
implantation rate;Clinical pregnancy rate;biochemical pregnancy rate;pregnancy loss rate;ectopic pregnancy rate;Congenital Anomalies rate;

Countries

China

Contacts

Public ContactHe-Feng Huang

International International Peace Maternity & Child Health Hospital

hefenghuang@126.com+86 18017310186

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026