Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.

NCT ID: NCT03272412

Last Updated: 2019-01-31

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

1205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-08

Study Completion Date

2018-11-28

Brief Summary

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This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.

Detailed Description

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Conditions

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Ongoing Pregnancy Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Analysis of serum Progesterone in blood sample

Levels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age \<50 years old
2. Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:

1. Embryos in fresh cycle with donated oocytes.
2. Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
3. Frozen embryo transfers in cycles with autologous oocytes.
3. Endometrial line: \>6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
4. Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
5. Embryo transfer of blastocyst (day 5-6).
6. Signed Informed Consent

Exclusion Criteria

1. Uterine pathology (submucous o intramural fibroids (\>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
2. Simultaneous participation in another clinical study.
3. Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.
Minimum Eligible Age

18 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

Gynecologist IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Valenciano de Infertilidad Spain

Valencia, , Spain

Site Status

Countries

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Spain

References

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Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.

Reference Type DERIVED
PMID: 33340402 (View on PubMed)

Other Identifiers

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1704-VLC-024-EL

Identifier Type: -

Identifier Source: org_study_id

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