Clinical trial NCT02941965: Preimplantation Genetic Screening in Patients With Male Factor Infertility
Official title: Preimplantation Genetic Screening in Patients With Male Factor Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Male
Diagnosis, Preimplantation
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 450
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: live birth rate
timeFrame: 42 weeks
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 35 days after embryo transfer
measure: implantation rate
timeFrame: 11-12 weeks after embryo transfer
measure: biochemical pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: pregnancy loss rate
timeFrame: 28 gestational weeks in maximum
measure: ectopic pregnancy rate
timeFrame: 12 gestational weeks in maximum
measure: Congenital Anomalies rate
timeFrame: 1 day after delivery
measure: neonatal complication rate
timeFrame: 1 day after delivery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity & Child Health Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: He-Feng Huang
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.