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HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05969834
Collaborator
(none)
100
Enrollment
1
Location
16.2
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome
Actual Study Start Date :
Mar 31, 2021
Actual Primary Completion Date :
Jul 19, 2022
Actual Study Completion Date :
Aug 7, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Oocyte maturation rate [On 1 day of oocyte retrieval]

      Number of mature oocytes divided by the number of retrieved oocytes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Center Mansoura Dakahlia Egypt 35516

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05969834
    Other Study ID Numbers:
    • MD.20.09.370
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mansoura University
    Ovulation triggering
    uHCG
    rHCG
    GnRH
    Dual trigger
    Additional relevant MeSH terms:
    Infertility
    Triptorelin Pamoate

    Study Results

    No Results Posted as of Aug 1, 2023