Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles

NCT ID: NCT02696694

Last Updated: 2016-11-29

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

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

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This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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P25-P75

serum progesterone between 25 and 75 percentile

Progesterone 25-75

Intervention Type OTHER

Impact of serum progesterone concentrations \[25-75\] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy

<P25 รณ >P75

serum progesterone \<25 or \>75 percentile

Progesterone <25, >75

Intervention Type OTHER

Impact of serum progesterone concentrations (\<25, \>75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy

Interventions

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Progesterone 25-75

Impact of serum progesterone concentrations \[25-75\] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy

Intervention Type OTHER

Progesterone <25, >75

Impact of serum progesterone concentrations (\<25, \>75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\<50 yo
* BMI \< 30Kg/m2
* Hormonal replacement cycle
* Endometrial thickness \>6.5 mm during proliferative phase
* Transfer of one or two blastocyst grade A-B according to ASEBIR

Exclusion Criteria

* Uterine pathology
* Cryptozoospermia
* Severe implantation failure (\>6 GQ embryos transferred without success)
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Elena Labarta

Elena Labarta, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.

Reference Type DERIVED
PMID: 29040638 (View on PubMed)

Other Identifiers

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IVI-EST-2015-01

Identifier Type: OTHER

Identifier Source: secondary_id

1511-VLC-061-EL

Identifier Type: -

Identifier Source: org_study_id