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

NCTNCT02342197Other id610012011

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 60 participants (actual)
Sponsor: Kasr El Aini Hospital · Other
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: Jan 2011
Primary completion: Dec 2011
Completion: Dec 2011
First posted: 19 Jan 2015 (estimated)
Last update posted: 28 Jan 2015 (estimated)
Conditions: Infertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20112012

Ph 3
Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation
NCT02342197
Jan 2011 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DecapeptylDrug

Arms2

Active comparator
Minidose long protocol
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.
Active comparator
Microdose flare protocol
Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Oocytes Retrieved
Time frame · 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 months

Number of Oocytes Retrieved

Group	Value (oocytes)	Spread
Minidose Long Protocol	4	1
Microdose Flare Protocol	3.4	0.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Minidose Long ProtocolHalf 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. Decapeptyl: half the dose of Gn agonist	–	0 / 0	0 / 0
Microdose Flare ProtocolHalf the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's Decapeptyl: half the dose of Gn agonist	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 35 Years up to 42 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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