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Phase 3 Completed N=60 Randomized Treatment

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

Source: ClinicalTrials.gov NCT02342197 ↗
Enrolled (actual)
60
Serious AEs
Results posted
Jan 2015
Primary outcomePrimary: Number of Oocytes Retrieved — 4; 3.4 oocytes

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Oocytes Retrieved
4; 3.4

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. Informational only — not medical advice.

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