Preimplantation Genetic Screening in Patients With Male Factor Infertility
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|ClinicalTrials.gov Identifier: NCT02941965|
Recruitment Status : Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : March 15, 2017
This will be a prospective, randomized (1:1 ratio) clinical trial for patients with male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 650 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (325 cases), Group B will undergo ICSI with PGS (690 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 male-factor infertility aged between 20 and 50 years, diagnosed by the ESHER Criteria (oligospermia and asthenspermia). Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place before 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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Male Diagnosis, Preimplantation||Procedure: ICSI without PGS Procedure: ICSI with PGS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preimplantation Genetic Screening in Patients With Male Factor Infertility|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: ICSI without PGS
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
Selection of embryos are based on morphology criteria on the 5th day of ICSI.
Experimental: ICSI with PGS
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
PGS will be applied to selected embryos on the 5th day of ICSI.
- live birth rate [ Time Frame: 42 weeks ]This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI as will all other secondary outcomes.
- clinical pregnancy rate [ Time Frame: 35 days after embryo transfer ]Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
- implantation rate [ Time Frame: 11-12 weeks after embryo transfer ]Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
- biochemical pregnancy rate [ Time Frame: 2 weeks after embryo transfer ]Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
- pregnancy loss rate [ Time Frame: 28 gestational weeks in maximum ]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 [ Time Frame: 12 gestational weeks in maximum ]Ectopic pregnancy is defined as an embryo implanted outside the uterine.
- Congenital Anomalies rate [ Time Frame: 1 day after delivery ]Congenital anomaly included deformity and development abnormality of any organs or systems.
- neonatal complication rate [ Time Frame: 1 day after delivery ]Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941965
|Contact: He-Feng Huang, MDfirstname.lastname@example.org|
|International Peace Maternity & Child Health Hospital||Not yet recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: He-feng Huang, MD +86-21-18017310186 email@example.com|
|Principal Investigator:||He-Feng Huang||Shanghai Jiao Tong University School of Medicine|