Preimplantation Genetic Screening in Patients With Male Factor Infertility

Infertility, Male Clinical Trial

Official title:

Preimplantation Genetic Screening in Patients With Male Factor Infertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02941965
• Other study ID #: IPMCH2016001
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: International Peace Maternity and Child Health Hospital
• Contact: He-Feng Huang, MD
• Phone: +86-21-18017310186
• Email: hefenghuang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 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 severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded.

The randomization will take place 3-6 days after 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion criteria

1. Male partner age of 20-55 years old, Chinese.

2. Male partner has severe male infertility (defined as a semen concentrate less than 5×10^6/ml, and/or with a progressive motility less than 10%).

3. Proposed ICSI to assist pregnancy.

4. Fully explain the nature of the research and obtain the informed consent of the subject before carrying out any procedure in the research protocol. If a subject is not capable of expressing opinions, the legal representative of the subject can sign the informed consent on behalf of the subject.

Exclusion criteria

Any one of the following criteria should be excluded from this study:

1. Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility.

2. Female partner at 38 years of ages and older.

3. Female partner has uterine abnormalities such as uterine malformations (unicornuate uterus, mediastinal uterus, double uterus, double horn uterus, etc.), adenomyosis, submucosal fibroids or intrauterine adhesions.

4. Female partner has a history of recurrent abortion, including biochemical pregnancy (=3 time miscarriages).

5. One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms.

6. Female partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease; history of cervical cancer, endometrial cancer or breast cancer; unexplained vaginal bleeding.

7. Male partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease.

8. One of the couple refuses to cooperate with the study.

9. Patients who have been included in the experimental group or control group of this study.

Related Conditions & MeSH terms

• Diagnosis, Preimplantation
• Infertility
• Infertility, Male

Intervention

Procedure:
• ICSI without PGS
Selection of embryos are based on morphology criteria on the 5th day of ICSI.
• ICSI with PGS
PGS will be applied to selected embryos on the 5th day of ICSI.

Locations

Country	Name	City	State
China	International Peace Maternity & Child Health Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.	42 weeks
Secondary	clinical pregnancy rate	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.	35 days after embryo transfer
Secondary	implantation rate	Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.	11-12 weeks after embryo transfer
Secondary	biochemical pregnancy rate	Biochemical pregnancy was defined as numbers of women with an elevated serum ß-hCG level of more than 10 mIU/ml.	2 weeks after embryo transfer
Secondary	pregnancy loss rate	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.	28 gestational weeks in maximum
Secondary	ectopic pregnancy rate	Ectopic pregnancy is defined as an embryo implanted outside the uterine.	12 gestational weeks in maximum
Secondary	Congenital Anomalies rate	Congenital anomaly included deformity and development abnormality of any organs or systems.	1 day after delivery
Secondary	neonatal complication rate	Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.	1 day after delivery