Triggering of Follicular Maturation

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

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

Study Overview

• Status: Completed
• Conditions: Increase Pregnancy Rate
• Intervention / Treatment: Drug: Recombinant Human Chorionic Gonadotrophin; Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of M II oocytes in both groups	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Fertilization rate in each group	3 days
Clinical pregnancy rate in each group	15 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: September 25, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormones; Chorionic Gonadotropin
• Other Study ID Numbers: FM-ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO