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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05751681
Enrollment
79
Registered
2023-03-02
Start date
2023-02-20
Completion date
2025-03-20
Last updated
2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovary Cyst, Fertility Issues

Keywords

IVF,ICSI,success rate

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

Interventions

OTHERprogestin primed ovarian stimulation protocol

progestin primed ovarian stimulation protocol

DRUGdydrogesterone (Duphaston, Abbott)

20 mg oral dose of dydrogesterone (Duphaston, Abbott)

0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy (Number of MII oocytes retrieved)3 monthsthis outcome means to measure Percentage (number) of MII oocytes retrieved During our study
Efficacy (Maturation index)3 monthsMaturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes

Countries

Egypt

Contacts

Primary Contactmostafa fahmy, mcs
mafahmy21@gmail.com01065644434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026