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

Ongoing Pregnancy Rate Clinical Trial

Official title:

Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272412
• Other study ID #: 1704-VLC-024-EL
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: January 2019
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1205
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ongoing Pregnancy Rate

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad Spain	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of serum Progesterone levels	Serum progesterone levels	The day of embryo transfer
Primary	Ongoing Pregnancies depending on Progesterone levels ranges.	Ultrasound to confirm Ongoing Pregnancy	Week 5-12 after Embryo Transfer