Triggering of Follicular Maturation

Assiut University

Status and phase: Completed; Phase 3

Conditions: Increase Pregnancy Rate

Treatments: Drug: Recombinant Human Chorionic Gonadotrophin; Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02916173

FM-ART

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Human chorionic gonadotrophin group

Experimental group

Description:

Patients will receive Human chorionic gonadotrohpin injection 5000 unit

Treatment:

Drug: Recombinant Human Chorionic Gonadotrophin

Human chorionic gonadotrophin + agonist group

Active Comparator group

Description:

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

Treatment:

Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist