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Synchronization of Follicle Wave Emergence and Ovarian Stimulation

NCT00439829 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-05-25

No results posted yet for this study

Summary

The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.

Conditions

Interventions

DRUG

Gonal F

* 450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork). * Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below). * Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS.

DRUG

Luveris

* 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met: * leading follicle is \> 13 mm in diameter * if 6 or more follicles develop to \> 10 mm and E2 \> 1000 pmol/L * Dosing to continue until administration of hCG (see below).

DRUG

Cetrotide

* 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met: * leading follicle is \> 13 mm in diameter * if 6 or more follicles develop to \> 10 mm and E2 \> 1000 pmol/L * Dosing to continue until administration of hCG (see below).

DRUG

hCG

\- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when: o \> 3 follicles are \> 17 mm in diameter

Sponsors & Collaborators

  • Royal University Hospital Foundation

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Angela R Baerwald, PhD · Dept OB/GYN, University of Saskatchewan

  • Allison M Case, MD FRCSC · Dept OB/GYN, University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439829 on ClinicalTrials.gov