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

Not Applicable

Recruiting

• Conditions: Fertility Issues; Ovary Cyst
• Interventions: Other: progestin primed ovarian stimulation protocol; Drug: Cetrotide; Drug: dydrogesterone (Duphaston, Abbott)

• Registration Number: NCT05751681
• Lead Sponsor: Zagazig University

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2022-12-14
• Study Start: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-04-20
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (B)	Cetrotide	Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.
Group (A)	progestin primed ovarian stimulation protocol	will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
Group (A)	dydrogesterone (Duphaston, Abbott)	will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
group (B)	progestin primed ovarian stimulation protocol	Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.

Primary Outcome Measures

Name	Time	Method
Efficacy (Maturation index)	3 months	Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Efficacy (Number of MII oocytes retrieved)	3 months	this outcome means to measure Percentage (number) of MII oocytes retrieved During our study

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt