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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ovary Cyst, Fertility Issues

Intervention / Treatment
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* Other: progestin primed ovarian stimulation protocol
* Drug: dydrogesterone (Duphaston, Abbott)
* Drug: Cetrotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients should be candidates for ICSI. Age between 20-40 years. Body mass index 18-35 kg/m2. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (A)<br>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. | Other: progestin primed ovarian stimulation protocol<br>* progestin primed ovarian stimulation protocol<br>Drug: dydrogesterone (Duphaston, Abbott)<br>* 20 mg oral dose of dydrogesterone (Duphaston, Abbott)<br>|
| Active Comparator: group (B)<br>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. | Other: progestin primed ovarian stimulation protocol<br>* progestin primed ovarian stimulation protocol<br>Drug: Cetrotide<br>* 0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)<br>* Other names: cetrorelix;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF,ICSI,success rate