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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03272412
Date of registration: 31/08/2017
Prospective Registration: Yes
Primary sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Public title: Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.
Scientific title: Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.
Date of first enrolment: September 8, 2017
Target sample size: 1205
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03272412
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Spain
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Ongoing Pregnancy Rate
Intervention(s)
Diagnostic Test: Analysis of serum Progesterone in blood sample
Primary Outcome(s)
Ongoing Pregnancies depending on Progesterone levels ranges. [Time Frame: Week 5-12 after Embryo Transfer]
Concentration of serum Progesterone levels [Time Frame: The day of embryo transfer]
Secondary Outcome(s)
Secondary ID(s)
1704-VLC-024-EL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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