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Trial record 15 of 423 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Triggering of Follicular Maturation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916173
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE September 25, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Number of M II oocytes in both groups [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2016)
Clinical pregnancy rate in each group [ Time Frame: 15 days ]
Change History Complete list of historical versions of study NCT02916173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Fertilization rate in each group [ Time Frame: 3 days ]
  • Clinical pregnancy rate in each group [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2016)
  • Fertilization rate [ Time Frame: 3 days ]
  • Number of M II oocyte [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triggering of Follicular Maturation
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Increase Pregnancy Rate
Intervention  ICMJE
  • Drug: Recombinant Human Chorionic Gonadotrophin
    250 unit intramuscular
    Other Name: Ovitrelle
  • Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
    250 unit intramuscular + 1 mg subcutaneous
Study Arms  ICMJE
  • Experimental: Human chorionic gonadotrophin group
    Patients will receive Human chorionic gonadotrohpin injection 5000 unit
    Intervention: Drug: Recombinant Human Chorionic Gonadotrophin
  • Active Comparator: Human chorionic gonadotrophin + agonist group
    patients will receive both Human chorionic gonadotrophin (2500 unit) and gonadotrophin releasing hormone agonist 1mg leuprolide acetate
    Intervention: Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2016)
148
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916173
Other Study ID Numbers  ICMJE FM-ART
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP