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Triggering of Follicular Maturation

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02916173
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
27
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and triggers ovulation approximately

Condition or Disease Intervention/Treatment Phase
  • Drug: Recombinant Human Chorionic Gonadotrophin
  • Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Triggering of Follicular Maturation Using Human Chorionic Gonadotrophin With Gonadotrophin Releasing Hormone Agonist Versus Human Chorionic Gonadotrophin Alone in Antagonist Protocol in Assisted Reproductive Technology : a Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Human chorionic gonadotrophin group

Patients will receive Human chorionic gonadotrohpin injection 5000 unit

Drug: Recombinant Human Chorionic Gonadotrophin
250 unit intramuscular
Other Names:
  • Ovitrelle

    		•
    Active Comparator: Human chorionic gonadotrophin + agonist group

    patients will receive both Human chorionic gonadotrophin (2500 unit) and gonadotrophin releasing hormone agonist 1mg leuprolide acetate

    Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
    250 unit intramuscular + 1 mg subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Number of M II oocytes in both groups [24 hours]

    Secondary Outcome Measures

    1. Fertilization rate in each group [3 days]

    2. Clinical pregnancy rate in each group [15 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Infertile couples wishing to do intracytoplasmic injection trial .

    2. first intracytoplasmic injection trial

    3. Body mass index:18-30.

    5-Antral follicular count: more than 5 follicles in one ovary 6-normal, mild or moderate male factor infertility. 7- Antimullerian hormone >1 ng/ml

    Exclusion Criteria:

    1. Azoospermic male.

    2. Body mass index more than 29.

    3. Patients with endometriosis .

    4. Antimullerian hormone < 1 ng/ml

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Abbas Assiut Cairo Egypt 002

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed Abbas, dr, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02916173
    Other Study ID Numbers:
    • FM-ART
    First Posted:
    Sep 27, 2016
    Last Update Posted:
    Mar 20, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Chorionic Gonadotropin
    Hormones

    Study Results

    No Results Posted as of Mar 20, 2019