Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)

NCT ID: NCT01356524

Last Updated: 2011-05-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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In Assisted Reproductive Techniques (ART) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of administration and dose has not yet been determined.

The aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in ART cycles. We also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.

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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Supplementary progesterone

Women with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone

Group Type ACTIVE_COMPARATOR

Additional vaginal progesterone

Intervention Type DRUG

The progesterone dose will be raised from 200 mg daily to 300 mg daily

No additional progesterone

No additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Additional vaginal progesterone

The progesterone dose will be raised from 200 mg daily to 300 mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mid-luteal serum progesterone levels below 15 ng/dl

Exclusion Criteria

* Does not sign consent form
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Nardin Aslih, MD

Role: primary

972-4-6304248

Other Identifiers

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HYH-28-11

Identifier Type: -

Identifier Source: org_study_id

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