The effect of calcium ionophore on fertilization rate after intracytoplasmic sperm injection in infertile couples with advanced female reproductive age : a randomized controlled trial

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230302001

Enrollment

160

Registered

2023-03-02

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile women that needs assisted reproductive technology by ICSI in advanced reproductive age group. Calcium ionophore, Artificial oocyte activation, ISCI, fertilization rate, Advanced reproductive age

Interventions

After ICSI about 15-30 minutes. OOcytes will be transfered to Calcium ionophere dish with a concentration of 10microM for 15 minutes. ,Conventional ICSI

Experimental Other,No Intervention Other

AOA by calcium ionophore for ICSI,Conventional ICSI

Eligibility

Sex/Gender

Female

Age

35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Infertile women that needs assisted reproductive technology by ICSI. 2. Infertile women from 35 years of age. 3. Diagnosed infertility by WHO criteria. 4. Cycle with more than or equal to 2 Metaphase II (MII) oocytes

Exclusion criteria

Exclusion criteria: 1. Couple with a chromosomal abnormality either in male or female. 2. Abnormal semen in male partner.

Design outcomes

Primary

Measure	Time frame
Fertilization rate 6 months 2 pronuclei (2PN) zygotes/MII oocyte x 100	—

Secondary

Measure	Time frame
Cleavage rate 6 months number of cleaved embryos on day 3/number of normally fertilized oocytes x 100,Good-quality cleavage rate 6 months number of good-quality cleavage embryos/number of normally fertilized oocytes x 100 ,Blastocyst formation rate 6 months number of blastocyst embryos/number of normally fertilized oocytes x 100 ,Good-quality blastocyst rate 6 months number of good-quality blastocyst embryos/number of normally fertilized oocytes x 100,Biochemical pregnancy rate 6 months number of positive hCG following embryo transfer/number of embryo transfer x 100 ,Clinical pregnancy rate 2 years number of positive fetal heart beat on ultrasonography/number of embryo transfer x 100 ,Live birth rate 2 years viable neonate at more than or equal to 28 weeks of gestation/number of embryo transfer x 100 ,Miscarriage rate 2 years number of pregnancy loss before gestational week 12/number of embryo transfer x 100	—

Measure

Time frame

Cleavage rate 6 months number of cleaved embryos on day 3/number of normally fertilized oocytes x 100,Good-quality cleavage rate 6 months number of good-quality cleavage embryos/number of normally fertilized oocytes x 100 ,Blastocyst formation rate 6 months number of blastocyst embryos/number of normally fertilized oocytes x 100 ,Good-quality blastocyst rate 6 months number of good-quality blastocyst embryos/number of normally fertilized oocytes x 100,Biochemical pregnancy rate 6 months number of positive hCG following embryo transfer/number of embryo transfer x 100 ,Clinical pregnancy rate 2 years number of positive fetal heart beat on ultrasonography/number of embryo transfer x 100 ,Live birth rate 2 years viable neonate at more than or equal to 28 weeks of gestation/number of embryo transfer x 100 ,Miscarriage rate 2 years number of pregnancy loss before gestational week 12/number of embryo transfer x 100

—

Countries

Thailand

Contacts

Public ContactSmith Ratanaphanyarat

Faculty of Medicine Siriraj Hospital, Mahidol University

smith.125@hotmail.com0843364511

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026