Phase 3 N=60 Randomized Treatment

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

Infertility

Bottom Line

View on ClinicalTrials.gov: NCT02342197 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jan 2015

Primary outcome: Primary: Number of Oocytes Retrieved — 4; 3.4 oocytes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Decapeptyl (Drug)
Age: Adult · 35+ yrs
Sex: Female
Sponsor: Kasr El Aini Hospital
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Oocytes Retrieved	4; 3.4	—

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.

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02342197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.