NCT01354275

Brief Summary

Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

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

March 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

May 12, 2011

Last Update Submit

February 1, 2012

Conditions

PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles

Keywords

PCOSIVF/ICSIClinical Pregnancy ratesGnRH AntagonistGnRH Agonist

Outcome Measures

Primary Outcomes (3)

  • Ongoing pregnancy rates

    Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS

    March 2009 to June 2011

  • clinical pregnancy rate

    To evaluate the clinical pregnancy rates of both study arms

    from march 2009 to july 2011

  • Total gonadotropin use

    Total gonadotropin use of both study arms

    From march 2009 to June 2011

Secondary Outcomes (2)

  • OHSS rates

    from march 2009 to july 2011

  • Total ongoing pregnancy rate

    from march 2009 to june 2011

Study Arms (2)

GnRH Agonist

ACTIVE COMPARATOR

oral contraceptive pill and GnRH Agonist IVF/ICSI cycle

Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle

GnRH Agonist Arm

ACTIVE COMPARATOR

Oral contraceptive pill and day 21 GnRH agonist began, Day 3 of menstruation 150 IU FSH will be started. If 3 or more follicle reach \>17 mm hCG will be administered.

Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycleOther: GnRH Antagonist

Interventions

To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycleOTHER

150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle

GnRH AgonistGnRH Agonist Arm
GnRH AntagonistOTHER

GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered

GnRH Agonist Arm

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS women undergoing ICSI cycles
  • All women will be administered 150 IU rec FSH

You may not qualify if:

  • Women having other endocrinopathies
  • women older than 35
  • third IVF/ICSI cycles
  • previous and current use of metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulent Haydardedeoglu

Adana, 01120, Turkey (Türkiye)

Location

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Study Officials

  • Bulent Haydardedeoglu, M.D.

    Baskent University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS: A Randomized Controlled Trial

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

March 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

TU(1)