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NCT05969834 Clinical Trial

HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

Infertility Clinical Trial

Official title:
Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05969834
Other study ID # MD.20.09.370
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2021
Est. completion date August 7, 2022

Study information
Verified date July 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose

Description:

The aims of this study are: 1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate 2. To determine if there is an association between type and dose of the trigger and ICSI outcome.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 7, 2022
Est. primary completion date July 19, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol Exclusion Criteria: - BMI > 30 kg/m2 - Irregular menstruation - Severe male factor abnormality - Poor ovarian reserve - Endometriosis - Uterine abnormality

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• uHCG
Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)
• rHCG
Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)
• uHCG and GnRHa
Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)

Locations
Country Name City State
Egypt Royal Center Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures 6 weeks after embryo transfer
Secondary Oocyte maturation rate Number of mature oocytes divided by the number of retrieved oocytes On 1 day of oocyte retrieval
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