NCT00461916

Brief Summary

The purpose of this study is to determine whether half-dose depot triptorelin are as effective as reduced-dose daily buserelin in the controlled ovarian stimulation for intracytoplasmic sperm injection and embryo transfer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

April 17, 2007

Last Update Submit

April 17, 2007

Conditions

Infertility

Keywords

half-dose depot triptorelinreduced-dose daily buserelincontrolled ovarian stimulationlong protocolICSI

Outcome Measures

Primary Outcomes (1)

  • Number of retrieved oocytes

Secondary Outcomes (14)

  • Number of days of gonadotropin stimulation

  • Number of hMG ampoules

  • Number of follicles at hCG administration

  • Quality of oocytes

  • Quality of embryos

  • +9 more secondary outcomes

Interventions

Half-Dose Depot TriptorelinDRUG
Reduced-Dose Daily BuserelinDRUG

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Candidate for ICSI/ET
  • years old or younger
  • Serum FSH less than 10 IU/l on day three of the previous menstrual cycle
  • No more than two previous IVF/ICSI attempts
  • No planned percutaneous epididymal sperm aspiration \[PESA\]
  • No planned testicular sperm extraction \[TESE\]
  • No known history or risk of severe hyperstimulation
  • No evidence of hydrosalpinx
  • No major systemic disease
  • No uterine abnormality
  • No previous ovarian surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Shariati Hospital

Tehran, Tehran Province, 14114, Iran

Location

Related Publications (1)

  • Safdarian L, Mohammadi FS, Alleyassin A, Aghahosseini M, Meysamie A, Rahimi E. Clinical outcome with half-dose depot triptorelin is the same as reduced-dose daily buserelin in a long protocol of controlled ovarian stimulation for ICSI/embryo transfer: a randomized double-blind clinical trial (NCT00461916). Hum Reprod. 2007 Sep;22(9):2449-54. doi: 10.1093/humrep/dem223. Epub 2007 Jul 17.

    PMID: 17635844DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Leili Safdarian, MD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

May 1, 2005

Study Completion

December 1, 2006

Last Updated

April 18, 2007

Record last verified: 2007-04

Locations

IR(1)