In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome

PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles Clinical Trial

— PCOS and ivf  

Official title:

IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01354275
• Other study ID #: BH532008
• Secondary ID: KA04/104
• Status: Terminated
• Phase: N/A
• First received: May 12, 2011
• Last updated: February 1, 2012
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Baskent University
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Bulent Haydardedeoglu	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Haydardedeoglu

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	clinical pregnancy rate	To evaluate the clinical pregnancy rates of both study arms	from march 2009 to july 2011	No
Primary	Total gonadotropin use	Total gonadotropin use of both study arms	From march 2009 to June 2011	No
Secondary	OHSS rates	OHSS rates in both study groups	from march 2009 to july 2011	No
Secondary	Total ongoing pregnancy rate	Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles.	from march 2009 to june 2011	No