Oral Estradiol Valerate Versus Oral Contraceptive Pill in... | NCT01501448

Studies
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

NCT01501448

Sponsor

IVI Madrid

Status

Completed

Last Update Posted

Mar 22, 2016Estimated

Enrollment

118Actual

Phase

Phase 4

Conditions

Infertility

Interventions

Levonorgestrel and ethinylestradiol
Estradiol valerate

Countries

Spain

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

Mar 2016

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

Jan 2012

Primary Completion Date

May 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 27, 2011

First Submission Date that Met QC Criteria

Dec 28, 2011

First Posted Date

Dec 29, 2011Estimated

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

Mar 20, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Description Module

Brief Summary

The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCP	Active Comparator		Drug: Levonorgestrel and ethinylestradiol
Oral estradiol valerate	Active Comparator		Drug: Estradiol valerate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel and ethinylestradiol	Drug	30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days	OCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implantation rate	number of embryonic sacs visible by ultrasound divided by the number of embryos transferred	20 days after the embryo transfer

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1st or 2nd IVF cycle
BMI <30 kg/m2
regular menstrual cycles
basal FSH <10IU and E2 <60pg/mL

Exclusion Criteria:

polycystic ovaries
endometriosis
previous ovarian surgery
previous low ovarian response

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVI Madrid		Madrid	Madrid	28223	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24074027	Derived	Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D019304	Ethinyl Estradiol-Norgestrel Combination
D004958	Estradiol

ID	Term
D004997	Ethinyl Estradiol
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids