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Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern

NCT01391845 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-07-20

No results posted yet for this study

Summary

Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2) serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated serum P levels leads to an accelerated endometrial maturation which interferes with the dialogue between embryo and endometrium. It has been reported that serum progesterone levels ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in the endometrial gene expression profile related to P elevated levels.

Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial epithelium and its expression seems to be related to the action of P. Because glycodelin-A has immunosuppressive activity, it may facilitate the process of implantation and the maintenance of pregnancy.

It is already know that ulipristal acetate (UPA) decrease serum P levels. The hypothesis of this study is that UPA is been able to modify P serum levels and glycodelin-A endometrial expression pattern on FSH/GnRH Antagonist cycles for FIV.

Conditions

Interventions

DRUG

ulipristal acetate

30mg of ulipristal acetate orally the day of hCG injection in a unique dose

DRUG

placebo

placebo orally in a unique dose the day of hCG injection

DRUG

ulipristal acetate

ulipristal acetate 30mg orally in a unique dose the day of hCG administration

DRUG

placebo

placebo orally in a unique dose the day of hCG injection

Sponsors & Collaborators

  • Programa de Asistencia Reproductiva de Rosario

    lead OTHER

Principal Investigators

  • Idelma Serpa, MD · PROAR-IUNIR

  • Carlos Morente, MD · Programa de Asistencia Reproductiva de Rosario

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • Argentina

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391845 on ClinicalTrials.gov