Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
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|ClinicalTrials.gov Identifier: NCT03120884|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female ART||Procedure: ICSI Procedure: IVF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1422 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||September 1, 2019|
embryos are cultured using conventional in vitro fertilization.A maximum of 2 embryos will be transferred for each treatment cycle.
A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.
Other Name: in vitro fertilization
embryos are fertilized using ICSI.A maximum of 2 embryos will be transferred for each treatment cycle.
A technique that involves microinjection of spermatozoa into mature oocytes.
Other Name: Intracytoplasmic Sperm Injection
- accumulated live birth rate [ Time Frame: 42 weeks ]This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes
- Fertilization rate [ Time Frame: 1 day after fertilization ]Fertilization rate was defined as the percentage of fetal heart beat among total retrieved oocytes
- Embryo quality [ Time Frame: 3day after fertilization ]Embryo quality was evaluated by microscopy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120884
|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, MD||Shanghai Jiao Tong University School of Medicine|