HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

Completed

• Conditions: Infertility
• Interventions: Drug: uHCG; Drug: rHCG; Drug: uHCG and GnRHa

• Registration Number: NCT05969834
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-03-31
• Primary Completion: 2022-07-19
• Study Completion: 2022-08-07
• Status Verified: 2023-07
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
uHCG group	uHCG	Trigger intramuscular (IM) administration of 10000 IU of uHCG
rHCG group	rHCG	Trigger with subcutaneous (SC) administration of 6500 IU of rHCG
Dual trigger group	uHCG and GnRHa	Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 weeks after embryo transfer	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

Secondary Outcome Measures

Name	Time	Method
Oocyte maturation rate	On 1 day of oocyte retrieval	Number of mature oocytes divided by the number of retrieved oocytes

Trial Locations

Locations (1)

Royal Center; 🇪🇬 Mansoura, Dakahlia, Egypt