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

Zagazig University

Status: Enrolling

Conditions: Ovary Cyst; Fertility Issues

Treatments: Drug: Cetrotide; Other: progestin primed ovarian stimulation protocol; Drug: dydrogesterone (Duphaston, Abbott)

Study type: Interventional

Funder types: Other

Identifiers

NCT05751681

9736-20-9-2022

Details and patient eligibility

About

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

Full 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

Enrollment: 79 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Group (A)

Experimental group

Description:

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.

Treatment:

Other: progestin primed ovarian stimulation protocol

Drug: dydrogesterone (Duphaston, Abbott)

group (B)

Active Comparator group

Description:

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.

Treatment:

Other: progestin primed ovarian stimulation protocol

Drug: Cetrotide