Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

Fertility Issues Clinical Trial

Official title:

Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751681
• Other study ID #: 9736-20-9-2022
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2023
• Source: Zagazig University
• Contact: mostafa fahmy, mcs
• Phone: 01065644434
• Email: mafahmy21[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

Description:

Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: March 20, 2025
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. All patients should be candidates for ICSI.

2. Age between 20-40 years.

3. Body mass index 18-35 kg/m2.

4. Diagnosis of PCOS according to modified Rotterdam's criteria

Exclusion Criteria:

• 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Ovary Cyst

Intervention

Other:
• progestin primed ovarian stimulation protocol
progestin primed ovarian stimulation protocol

Drug:
• dydrogesterone (Duphaston, Abbott)
20 mg oral dose of dydrogesterone (Duphaston, Abbott)
• Cetrotide
0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (Number of MII oocytes retrieved)	this outcome means to measure Percentage (number) of MII oocytes retrieved During our study	3 months
Primary	Efficacy (Maturation index)	Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes	3 months