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Trial record 15 of 417 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

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
Increase Pregnancy Rate Drug: Recombinant Human Chorionic Gonadotrophin Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: 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




Primary Outcome Measures :
  1. Number of M II oocytes in both groups [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Fertilization rate in each group [ Time Frame: 3 days ]
  2. Clinical pregnancy rate in each group [ Time Frame: 15 days ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916173


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, dr, Assiut University
ClinicalTrials.gov Identifier: NCT02916173     History of Changes
Other Study ID Numbers: FM-ART
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents