hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle | NCT00398229

Studies
hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle

NCT00398229

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Jan 1, 2009Estimated

Enrollment

300Estimated

Phase

Phase 2

Conditions

Fertility Agents, Female

Interventions

s.c. human chorionic gonadotropin (Ovitrelle)

Countries

Israel

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

Nov 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

Nov 2006

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Nov 9, 2006

First Submission Date that Met QC Criteria

Nov 9, 2006

First Posted Date

Nov 10, 2006Estimated

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

Dec 31, 2008

Last Update Posted Date

Jan 1, 2009Estimated

Description Module

Brief Summary

The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	receiving hCG injection	Drug: s.c. human chorionic gonadotropin (Ovitrelle)
B	Placebo Comparator		Drug: s.c. human chorionic gonadotropin (Ovitrelle)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
s.c. human chorionic gonadotropin (Ovitrelle)	Drug	S.C. Ovitrelle 250 mcg once	A B

Measure	Description	Time Frame
implantation rate		4 weeks
pregnancy rate		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all women on frozen-thawed embryo-transfer cycle

Exclusion Criteria:

any allergy to injection of human chorionic gonadotropin before

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Assaf Ben-Meir, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical center		Jerusalem			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

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