Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes

NCT05972902 | Unknown Phase 3

• 1 other identifier: Dydrogesterone IVF
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention of premature LH surge and quality of retrieved oocytes and embryos in women undergoing intra-cytoplasmic sperm injection.

Conditions

IVF

Keywords

Dydrogesterone; Intra Cytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (2)

• Number of oocytes retrieved.

  number of oocytes

  1cycle (1 month)

• maturity of oocytes retrieved.

  either M2 or M1

  1 cycle (1month)

Secondary Outcomes (1)

• Duration of stimulation

  1 ICSI cycle (1 month)

Study Arms (3)

Dydrogesterone

EXPERIMENTAL

For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.

Drug: Dydrogesterone

GnRH antagonist

ACTIVE COMPARATOR

For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.

Drug: Cetrorelix acetate

GnRH agonist

ACTIVE COMPARATOR

For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation

Drug: Triptorelin

Interventions

Dydrogesterone DRUG

Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone

Also known as: Duphaston

Dydrogesterone

Cetrorelix acetate DRUG

GnRH antagonist

Also known as: cetrotide

GnRH antagonist

Triptorelin DRUG

GnRH agonist

Also known as: Decapeptyl, sc 0.1 mg/day

GnRH agonist

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having indications for ICSI.

You may not qualify if:

• Any known contraindications to the approved fertility drugs.
• Severe endometriosis.
• Uterine malformations or abnormal uterine cavity.
• Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
• Severe male factor for infertility.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

MeSH Terms

Interventions

Dydrogesterone; cetrorelix; Triptorelin Pamoate

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: July 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

EG (1)