Preimplantation Genetic Screening in Patients With Male Factor Infertility

NCT02941965 | Unknown DMC

• 1 other identifier: IPMCH2016001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Male; Diagnosis, Preimplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• clinical pregnancy rate

  35 days after embryo transfer

• implantation rate

  11-12 weeks after embryo transfer

• biochemical pregnancy rate

  2 weeks after embryo transfer

• pregnancy loss rate

  28 gestational weeks in maximum

• ectopic pregnancy rate

  12 gestational weeks in maximum

Study Arms (2)

ICSI without PGS

EXPERIMENTAL

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

ICSI with PGS

EXPERIMENTAL

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

Interventions

ICSI without PGS PROCEDURE

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

ICSI without PGS

ICSI with PGS PROCEDURE

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

ICSI with PGS

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

International Peace Maternity & Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (3)

• Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H. Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial. BMJ. 2025 Dec 23;391:e084050. doi: 10.1136/bmj-2025-084050.

  PMID: 41436190 DERIVED

• 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.

  PMID: 35831058 DERIVED

• 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.

  PMID: 32898291 DERIVED

MeSH Terms

Conditions

Infertility, Male; Disease

Interventions

Sperm Injections, Intracytoplasmic; Phosphatidylglycerols

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• He-Feng Huang

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He-Feng Huang, MD

CONTACT

+86-21-18017310186; hefenghuang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: July 18, 2017
• Primary Completion: August 30, 2022
• Study Completion: June 30, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)