NCT00436319

Brief Summary

The purpose of this study is to assess whether the probability of pregnancy is dependent on the duration of GnRH agonist downregulation in IVF cycles.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

9.1 years

First QC Date

February 16, 2007

Last Update Submit

February 11, 2016

Conditions

Infertility

Keywords

Infertility, downregulation, stimulation, agonists, long

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    2 years

Study Arms (2)

1

NO INTERVENTION

In the control group (group 1) the initiation of the ovarian stimulation will be realized according to the typical long luteal protocol, two weeks after the initiation of the GnRH agonist administration.

2

OTHER

In the study group (group 2) the initiation of the ovarian stimulation will be effectuated on the second day of the menstrual period.

Procedure: Duration of GnRH agonist downregulation

Interventions

Duration of GnRH agonist downregulationPROCEDURE

This is a randomized controlled trial. Patients will be randomized to two groups during the first consultation. GnRH agonist will be administrated according to the long luteal protocol. Down-regulation of the pituitary will be controlled on the first day of the menstrual period. The purpose of this study is to compare the pregnancy rates between the two groups. In the eventuality that pituitary down-regulation has not been confirmed (down-regulation levels determined as Ε2\<80 pg/ml and progesterone \<1.6 ng/ml), the patient will be assigned to a third group (group 3) and ovarian stimulation will only be initiated after down-regulation has been confirmed. The GnRH agonist that will be administrated is Buserelin Acetate. Recombinant FSH will be used for the ovarian stimulation and dose determination will be based on patient characteristics and previous history.

2

Eligibility Criteria

Age19 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age under 39
  • less than 3 previous IVF cycles
  • BMI 18-29
  • normal ultrasound of internal genital organs

You may not qualify if:

  • polycystic ovarian syndrome
  • endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece

Thessaloniki, Greece

Location

Related Publications (2)

  • Damario MA, Moomjy M, Tortoriello D, Moy F, Davis OK, Rosenwaks Z. Delay of gonadotropin stimulation in patients receiving gonadotropin-releasing hormone agonist (GnRH-a) therapy permits increased clinic efficiency and may enhance in vitro fertilization (IVF) pregnancy rates. Fertil Steril. 1997 Dec;68(6):1004-10. doi: 10.1016/s0015-0282(97)00392-0.

    PMID: 9418688BACKGROUND

  • Kolibianakis EM, Papanikolaou EG, Camus M, Tournaye H, Van Steirteghem AC, Devroey P. Menstruation-free interval and ongoing pregnancy in IVF using GnRH antagonists. Hum Reprod. 2006 Apr;21(4):1012-7. doi: 10.1093/humrep/dei415. Epub 2005 Dec 8.

    PMID: 16339166BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Basil C Tarlatzis, MD PhD

    Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

May 1, 2006

Primary Completion

June 1, 2015

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

GR(1)