Substituted Frozen Embryo Transfer Cycles With GnRH-agoni... | NCT01943812

Studies
Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation

NCT01943812

Sponsor

Peter Humaidan

Status

Completed

Last Update Posted

Jun 23, 2020Actual

Enrollment

287Actual

Phase

Phase 4

Conditions

Pregnancy Loss
Frozen Embryo Transfer

Interventions

Estradiol and progeterone

Countries

Denmark

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 2020

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

Dec 2013

Primary Completion Date

Apr 2019Actual

Completion Date

Apr 2020Actual

First Submitted Date

Sep 12, 2013

First Submission Date that Met QC Criteria

Sep 16, 2013

First Posted Date

Sep 17, 2013Estimated

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 22, 2020

Last Update Posted Date

Jun 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.

Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Substituted FET cycle and GnRHa	Experimental	Substituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg	Drug: Estradiol and progeterone
Substituted FET cycle	Active Comparator	substituted FET cycle Estradiol Progesterone	Drug: Estradiol and progeterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Estradiol and progeterone	Drug	Estradiol and progesterone	Substituted FET cycle Substituted FET cycle and GnRHa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy loss rate		Primary outcome is avaible after 12th week of gestational.

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate		14 days after embryo transfer.

Other Outcomes

Measure	Description	Time Frame
Luteal progesterone levels		7th week of gestation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Endometrial thickness ≥ 7 mm after stimulation
18-45 years
IVF/ICSI fertilisation
BMI > 18,5 <30 kg/m2
cycle length 25-34 days

Exclusion Criteria:

endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles
Uterine abnormality
Chronic medical disease
oocyte donation cycles

Accepts Healthy Volunteers

Yes

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
Birgit Alsbjerg, M.D.	Fertility Clinic Regional Hospital Skive	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVF syd		Fredericia		7000	Denmark
Fertility Clinic Regional Hospital Skive

Intervention Browse Module

MeSH Terms

ID	Term
D004958	Estradiol
D011374	Progesterone

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided