Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age

Infertility, Female Clinical Trial

Official title:

Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03120884
• Other study ID #: IPMCH2017001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 16, 2017
• Last updated: April 16, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: April 2017
• Source: International Peace Maternity and Child Health Hospital
• Contact: He-Feng Huang, MD
• Phone: +86-21-18017310186
• Email: hefenghuang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1422
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 38 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female patients ages =38 years old with FSH =15;

• Spouse with normal sperm analysis according to WHO fifth edition criteria(sperm parameter values: total sperm count of at least 39 million, concentration=15 × 106/ml, total motility =40%, progressive motility =32%, strict morphology =4% normal forms);

• Female patients who intended to undergo IVF and had signed a written consent form.

Exclusion Criteria:

• More than three previous IVF cycles (including both failed cycles and cycles that ended in live births)

• Female patients with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility; Female patients who have previously been diagnosed with a uterine abnormality such as a malformed uterus(uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;

• Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;

• Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region

• the use of donor oocytes or sperm;

• the use of frozen oocytes or sperm;

• Femal patients with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding;

• Spouse with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease;

• Female patients or their partners who are unable to comply with the study Procedures;

• Female patients who had previously been randomized to either of the two study groups in this trial.

Related Conditions & MeSH terms

• ART
• Infertility
• Infertility, Female

Intervention

Procedure:
• ICSI
A technique that involves microinjection of spermatozoa into mature oocytes.
• IVF
A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.

Locations

Country	Name	City	State
China	International Peace Maternity & Child Health Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accumulated live birth rate	This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes	42 weeks
Secondary	Fertilization rate	Fertilization rate was defined as the percentage of fetal heart beat among total retrieved oocytes	1 day after fertilization
Secondary	Embryo quality	Embryo quality was evaluated by microscopy.	3day after fertilization
Secondary	clinical pregnancy rate	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.	35 days after embryo transfer
Secondary	implantation rate	Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.	11-12 weeks after embryo transfer
Secondary	biochemical pregnancy rate	Biochemical pregnancy was defined as numbers of women with an elevated serum ß-hCG level of more than 10 mIU/ml.	2 weeks after embryo transfer
Secondary	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.	28 gestational weeks in maximum
Secondary	ectopic pregnancy rate	Ectopic pregnancy is defined as an embryo implanted outside the uterine.	12 gestational weeks in maximum