Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation

NCT02342197 | Completed Phase 3 Results

• 1 other identifier: 610012011
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To compare two stimulation protocols, the minidose long protocol and the microdose flare protocol designed for low responders undergoing ICSI. Design: Randomized prospective study. Setting: University hospital IVF unit. Patients: 60 poor responder patients coming for IVF center for ICSI. Interventions: Minidose long protocol in which half the dose of agonist was administered from the mid luteal phase until the day of HCG administration was compared with microdose flare protocol in which half the dose of GnRH was administered from the second day of the cycle until the day of HCG administration. Both groups received Gn stimulation from the second day of the cycle (300-450 IU). Main outcome measures: Number of oocytes retrieved.

Conditions

Infertility

Keywords

Low responders; Minidose long protocol; Microdose flare protocol; Oocyte yield

Outcome Measures

Primary Outcomes (1)

• Number of Oocytes Retrieved

  12 months

Study Arms (2)

Minidose long protocol

ACTIVE COMPARATOR

Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.

Drug: Decapeptyl

Microdose flare protocol

ACTIVE COMPARATOR

Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's

Drug: Decapeptyl

Interventions

Decapeptyl DRUG

half the dose of Gn agonist

Also known as: GnRH agonist

Microdose flare protocol; Minidose long protocol

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 35 years
• Day 3 serum FSH level \> 10m IU/ml
• Number of antral follicles measuring 4-8mm during the early phase \< 6
• Small ovarian volume
• AMH \< 1
• Prior poor ovarian response to COH (oocytes \< 5)

You may not qualify if:

• Polycystic ovarian syndrome patients
• Patients with Endometriosis
• Normal responders to ovulation induction
• Patients having ovarian cyst
• Patients receiving ovulation induction in the preceding cycle

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nawara Mohamed
• Organization: Kasr El-Aini Hospital

nawaram@kasrelaini.edu.eg

0223654060

Publication Agreements

• PI is Sponsor Employee: Yes

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: Nawara Hashish

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: January 19, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2015
• Results First Posted: January 28, 2015

Record last verified: 2015-01