HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

NCT ID: NCT05969834

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-08-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

uHCG group

Trigger intramuscular (IM) administration of 10000 IU of uHCG

uHCG

Intervention Type DRUG

Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)

rHCG group

Trigger with subcutaneous (SC) administration of 6500 IU of rHCG

rHCG

Intervention Type DRUG

Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)

Dual trigger group

Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG

uHCG and GnRHa

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

uHCG

Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)

Intervention Type DRUG

rHCG

Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)

Intervention Type DRUG

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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Choriomon Ovitrelle Decapeptyl and Choriomon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Engy Abdallah, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, MD

Role: STUDY_DIRECTOR

Mansoura University

Mohamed Elzayat, MD

Role: STUDY_CHAIR

Royal Center

Amoura Abou-ElNaga, MD

Role: STUDY_CHAIR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MD.20.09.370

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.