HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

July 31, 2023 updated by: Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Royal Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
uHCG group
Trigger intramuscular (IM) administration of 10000 IU of uHCG
Drug: uHCG
Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)
Other Names:
  • Choriomon
rHCG group
Trigger with subcutaneous (SC) administration of 6500 IU of rHCG
Drug: rHCG
Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)
Other Names:
  • Ovitrelle
Dual trigger group
Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG
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)
Other Names:
  • Decapeptyl and Choriomon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 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
6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte maturation rate
Time Frame: On 1 day of oocyte retrieval
Number of mature oocytes divided by the number of retrieved oocytes
On 1 day of oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Engy Abdallah, MSc, Mansoura University
  • Study Director: Mohamed S Abdelhafez, MD, Mansoura University
  • Study Chair: Mohamed Elzayat, MD, Royal Center
  • Study Chair: Amoura Abou-ElNaga, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

August 7, 2022

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.20.09.370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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