Trial record 16 of 380 for:    PCOS

In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome (PCOS and ivf)

This study has been terminated.
(. The trial would be continued if there was a difference of ≥3 % between trial arms. However, the difference between ongoing pregnancy rates was <1 %)
Sponsor:
Information provided by (Responsible Party):
Bulent Haydardedeoglu, Baskent University
ClinicalTrials.gov Identifier:
NCT01354275
First received: May 12, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles
Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle
Other: GnRH Antagonist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • Ongoing pregnancy rates [ Time Frame: March 2009 to June 2011 ] [ Designated as safety issue: No ]
    Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS

  • clinical pregnancy rate [ Time Frame: from march 2009 to july 2011 ] [ Designated as safety issue: No ]
    To evaluate the clinical pregnancy rates of both study arms

  • Total gonadotropin use [ Time Frame: From march 2009 to June 2011 ] [ Designated as safety issue: No ]
    Total gonadotropin use of both study arms


Secondary Outcome Measures:
  • OHSS rates [ Time Frame: from march 2009 to july 2011 ] [ Designated as safety issue: No ]
    OHSS rates in both study groups

  • Total ongoing pregnancy rate [ Time Frame: from march 2009 to june 2011 ] [ Designated as safety issue: No ]
    Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles.


Enrollment: 300
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GnRH Agonist
oral contraceptive pill and GnRH Agonist IVF/ICSI cycle
Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle
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
Active Comparator: GnRH Agonist Arm
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 cycle
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
Other: GnRH Antagonist
GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered

Detailed Description:

Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women having other endocrinopathies
  • women older than 35
  • third IVF/ICSI cycles
  • previous and current use of metformin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354275

Locations
Turkey
Bulent Haydardedeoglu
Adana, Turkey, 01120
Sponsors and Collaborators
Bulent Haydardedeoglu
Investigators
Study Chair: Bulent Haydardedeoglu, M.D. Baskent University
  More Information

No publications provided

Responsible Party: Bulent Haydardedeoglu, IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS: A Randomized Controlled Trial, Baskent University
ClinicalTrials.gov Identifier: NCT01354275     History of Changes
Other Study ID Numbers: BH532008, KA04/104
Study First Received: May 12, 2011
Last Updated: February 1, 2012
Health Authority: Turkey: Baskent University

Keywords provided by Baskent University:
PCOS
IVF/ICSI
Clinical Pregnancy rates
GnRH Antagonist
GnRH Agonist

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Deslorelin
Triptorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014