NCT01356524

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

May 18, 2011

Last Update Submit

May 18, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rates

    One week

Study Arms (2)

Supplementary progesterone

ACTIVE COMPARATOR

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

Drug: Additional vaginal progesterone

No additional progesterone

NO INTERVENTION

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

Interventions

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

Supplementary progesterone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Does not sign consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 19, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations