Back to results

Preimplantation Genetic Screening in Patients With Male Factor Infertility

Primary Purpose

Infertility, Male, Diagnosis, Preimplantation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ICSI without PGS

ICSI with PGS

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

20 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion criteria

Male partner age of 20-55 years old, Chinese.
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%).
Proposed ICSI to assist pregnancy.
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:

Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility.
Female partner at 38 years of ages and older.
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.
Female partner has a history of recurrent abortion, including biochemical pregnancy (≥3 time miscarriages).
One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms.
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.
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.
One of the couple refuses to cooperate with the study.
Patients who have been included in the experimental group or control group of this study.

Sites / Locations

International Peace Maternity & Child Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ICSI without PGS

ICSI with PGS

Arm Description

Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

clinical pregnancy rate

Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.

implantation rate

Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.

biochemical pregnancy rate

Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.

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.

ectopic pregnancy rate

Ectopic pregnancy is defined as an embryo implanted outside the uterine.

Congenital Anomalies rate

Congenital anomaly included deformity and development abnormality of any organs or systems.

neonatal complication rate

Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.

Full Information

NCT ID

NCT02941965

First Posted

October 19, 2016

Last Updated

June 1, 2022

Sponsor

International Peace Maternity and Child Health Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02941965

Brief Title

Preimplantation Genetic Screening in Patients With Male Factor Infertility

Official Title

Preimplantation Genetic Screening in Patients With Male Factor Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2017 (Actual)

Primary Completion Date

August 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

International Peace Maternity and Child Health Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Male, Diagnosis, Preimplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICSI without PGS

Arm Type

Experimental

Arm Description

Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.

Arm Title

ICSI with PGS

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

ICSI without PGS

Intervention Description

Selection of embryos are based on morphology criteria on the 5th day of ICSI.

Intervention Type

Procedure

Intervention Name(s)

ICSI with PGS

Intervention Description

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

Primary Outcome Measure Information:

Title

live birth rate

Description

This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.

Time Frame

42 weeks

Secondary Outcome Measure Information:

Title

clinical pregnancy rate

Description

Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.

Time Frame

35 days after embryo transfer

Title

implantation rate

Description

Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.

Time Frame

11-12 weeks after embryo transfer

Title

biochemical pregnancy rate

Description

Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.

Time Frame

2 weeks after embryo transfer

Title

pregnancy loss rate

Description

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.

Time Frame

28 gestational weeks in maximum

Title

ectopic pregnancy rate

Description

Ectopic pregnancy is defined as an embryo implanted outside the uterine.

Time Frame

12 gestational weeks in maximum

Title

Congenital Anomalies rate

Description

Congenital anomaly included deformity and development abnormality of any organs or systems.

Time Frame

1 day after delivery

Title

neonatal complication rate

Description

Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.

Time Frame

1 day after delivery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Male partner age of 20-55 years old, Chinese. 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%). Proposed ICSI to assist pregnancy. 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: Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility. Female partner at 38 years of ages and older. 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. Female partner has a history of recurrent abortion, including biochemical pregnancy (≥3 time miscarriages). One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms. 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. 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. One of the couple refuses to cooperate with the study. Patients who have been included in the experimental group or control group of this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

He-Feng Huang, MD

Phone

+86-21-18017310186

hefenghuang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

He-Feng Huang

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Peace Maternity & Child Health Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

He-feng Huang, MD

Phone

+86-21-18017310186

hefenghuang@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35831058

Citation

Lin XH, Guo MX, Wu DD, Lu Y, Zhang JL, Zhou CL, Jin L, Wang L, Zhang C, Xu CM, Chen SC, Zhang SY, Sun XX, Wu YT, Sun Y, Huang HF. Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial. BMJ Open. 2022 Jul 13;12(7):e063030. doi: 10.1136/bmjopen-2022-063030.

Results Reference

derived

PubMed Identifier

32898291

Citation

Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.

Results Reference

derived

Learn more about this trial

Preimplantation Genetic Screening in Patients With Male Factor Infertility

We'll reach out to this number within 24 hrs