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

NCT05751681 | Unknown

• 1 other identifier: 9736-20-9-2022
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Ovary Cyst; Fertility Issues

Keywords

IVF,ICSI,success rate

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group (A)

EXPERIMENTAL

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; Drug: dydrogesterone (Duphaston, Abbott)

group (B)

ACTIVE COMPARATOR

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; Drug: Cetrotide

Interventions

progestin primed ovarian stimulation protocol OTHER

progestin primed ovarian stimulation protocol

Group (A); group (B)

dydrogesterone (Duphaston, Abbott) DRUG

20 mg oral dose of dydrogesterone (Duphaston, Abbott)

Group (A)

Cetrotide DRUG

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

Also known as: cetrorelix

group (B)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: 20-40 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, 44511, Egypt

RECRUITING

MeSH Terms

Conditions

Ovarian Cysts; Infertility

Interventions

Dydrogesterone; cetrorelix

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• mostafa fahmy, mcs

  zagazig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mostafa fahmy, mcs

CONTACT

01065644434; mafahmy21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: March 2, 2023
• Study Start: February 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: March 20, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)