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

Not Applicable

Terminated

• Conditions: PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles
• Interventions: Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle; Other: GnRH Antagonist

• Registration Number: NCT01354275
• Lead Sponsor: Bulent Haydardedeoglu

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-03
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GnRH Agonist	To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle	oral contraceptive pill and GnRH Agonist IVF/ICSI cycle
GnRH Agonist Arm	To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle	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.
GnRH Agonist Arm	GnRH Antagonist	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rates	March 2009 to June 2011	Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS
clinical pregnancy rate	from march 2009 to july 2011	To evaluate the clinical pregnancy rates of both study arms
Total gonadotropin use	From march 2009 to June 2011	Total gonadotropin use of both study arms

Secondary Outcome Measures

Name	Time	Method
OHSS rates	from march 2009 to july 2011	OHSS rates in both study groups
Total ongoing pregnancy rate	from march 2009 to june 2011	Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles.

Trial Locations

Locations (1)

Bulent Haydardedeoglu; 🇹🇷 Adana, Turkey