Pregnancy Outcomes With a GnRH Antagonist Protocol Versus... | NCT00485537

Studies
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles

NCT00485537

Sponsor

Clinic and Research Center in Human Reproduction Roger Abdelmassih

Status

Completed

Last Update Posted

Jun 13, 2007Estimated

Enrollment

2,005Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

oocyte retrieval and ICSI procedure

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2007

Last Update Posted Date

Jun 13, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Clinic and Research Center in Human Reproduction Roger AbdelmassihOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.

Detailed Description

160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,005Actual

Name	Type	Description	Arm Group Labels	Other Names
oocyte retrieval and ICSI procedure	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparative response to ICSI cycles with GnRH agosnist and cetrotide		16 months

Secondary Outcomes

Measure	Description	Time Frame
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups		16 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels < 12 IU/l, basal levels of estradiol < 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound

Exclusion Criteria:

use of exogenous LH during stimulation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosa M Neme, MD,PhD	Clinic and Research Center in Human Reproduction Roger Abdelmassih	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica e Centro de Reprodução Humana Roger Abdelmassih		São Paulo	São Paulo	01431-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054315	Oocyte Retrieval

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D020858	Tissue and Organ Harvesting

Browse Leaves

Not provided

Browse Branches

Not provided