Triggering of Follicular Maturation

NCT ID: NCT02916173

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-02-28

Brief Summary

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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

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Conditions

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Increase Pregnancy Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human chorionic gonadotrophin group

Patients will receive Human chorionic gonadotrohpin injection 5000 unit

Group Type EXPERIMENTAL

Recombinant Human Chorionic Gonadotrophin

Intervention Type DRUG

250 unit intramuscular

Human chorionic gonadotrophin + agonist group

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

Group Type ACTIVE_COMPARATOR

human chorionic gonadotrophin + gonadotrophin releasing hormone agonist

Intervention Type DRUG

250 unit intramuscular + 1 mg subcutaneous

Interventions

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Recombinant Human Chorionic Gonadotrophin

250 unit intramuscular

Intervention Type DRUG

human chorionic gonadotrophin + gonadotrophin releasing hormone agonist

250 unit intramuscular + 1 mg subcutaneous

Intervention Type DRUG

Other Intervention Names

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Ovitrelle

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FM-ART

Identifier Type: -

Identifier Source: org_study_id

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