Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

NCT ID: NCT01501448

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCP

Group Type ACTIVE_COMPARATOR

Levonorgestrel and ethinylestradiol

Intervention Type DRUG

30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days

Oral estradiol valerate

Group Type ACTIVE_COMPARATOR

Estradiol valerate

Intervention Type DRUG

4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle

Interventions

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Levonorgestrel and ethinylestradiol

30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days

Intervention Type DRUG

Estradiol valerate

4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVI Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 24074027 (View on PubMed)

Other Identifiers

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IVIMAD-GV-OCPE-2011

Identifier Type: -

Identifier Source: org_study_id

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