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

NCT03272412 | Completed

• 1 other identifier: 1704-VLC-024-EL
• Study Type: observational
• Target: 1,205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ongoing Pregnancy Rate

Outcome Measures

Primary Outcomes (2)

• Concentration of serum Progesterone levels

  Serum progesterone levels

  The day of embryo transfer

• Ongoing Pregnancies depending on Progesterone levels ranges.

  Ultrasound to confirm Ongoing Pregnancy

  Week 5-12 after Embryo Transfer

Interventions

Analysis of serum Progesterone in blood sample DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who are undergoing IVF treatments with artificial endometrial preparation with hormonal replacement therapy.

You may qualify if:

• Age \<50 years old
• Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:
• Embryos in fresh cycle with donated oocytes.
• Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
• Frozen embryo transfers in cycles with autologous oocytes.
• Endometrial line: \>6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
• 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.
• Embryo transfer of blastocyst (day 5-6).
• Signed Informed Consent

You may not qualify if:

• Uterine pathology (submucous o intramural fibroids (\>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
• Simultaneous participation in another clinical study.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad Spain

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 33340402 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist IVI Valencia

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: September 8, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

ES (1)