NCT01391845

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

June 28, 2011

Last Update Submit

July 19, 2011

Conditions

Infertility

Keywords

progesteroneglycodelin-Aulipristal acetate

Outcome Measures

Primary Outcomes (1)

  • Changes in Glycodelin-A endometrial expression pattern and Progesterone serum levels in women expose to ulipristal acetate on stimulated ovarian cycles for FIV

    to evaluate Glycodelin-A expression pattern by immunohistochemistry and Progesterone serum levels on women exposed or not to ulipristal acetate in FSH/GnRH Antagonist protocol.

    participants will be followed for the duration of one mesntrual cycle, from day 1 of the cycle until day 28-32

Secondary Outcomes (3)

  • P levels during controlled ovarian stimulation since at least one follicle achieve ≥14mm of diameter

    participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32

  • Serum P levels on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation

    participants will be followed for the duration of one mesntrual cycle,from day 1 until day 28-32

  • Glycodelin-A endometrial expression pattern on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation

    participants will be followed for the duration of one mesntrual cycle, from day 1 until day 28-32

Study Arms (4)

UPA, 300UI FSH

EXPERIMENTAL

patients on COS with 300UI FSHu/GnRH Antagonist protocol and ulipristal acetate use

Drug: ulipristal acetate

No UPA, 300FSH

PLACEBO COMPARATOR

patients on COS with 300UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use

Drug: placebo

UPA, FSH 225

EXPERIMENTAL

patients on COS with 225UI FSHu/GnRH Antagonist protocol and ulipristal acetate use

Drug: ulipristal acetate

no UPA, FSH225

PLACEBO COMPARATOR

patients on COS with 225UI FSHu/GnRH Antagonist protocol and without ulipristal acetate use

Drug: placebo

Interventions

ulipristal acetateDRUG

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

Also known as: UPA/FSH 300
UPA, 300UI FSH
placeboDRUG

placebo orally in a unique dose the day of hCG injection

Also known as: No UPA/FSH 300
No UPA, 300FSH

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \<35 years old
  • FSH on day 3: \<12 UI/ml
  • Antral follicular count ≥ 6 on day 3 of the cycle
  • BMI: \<30 Kg/m2

You may not qualify if:

  • Hypothyroidism
  • Hyperprolactinemia
  • Kidney or liver disease
  • Smoking
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROAR (Programa de Asistencia Reproductiva de Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

Infertility

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Idelma Serpa, MD

    PROAR-IUNIR

    PRINCIPAL INVESTIGATOR

  • Carlos Morente, MD

    Programa de Asistencia Reproductiva de Rosario

    STUDY CHAIR

Central Study Contacts

Idelma Serpa, MD

CONTACT

+54 0341 155668963idelmaserpa@yahoo.com.ar

Idelma Serpa, MD

CONTACT

idelmaserpa@yahoo.com.ar

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 12, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-05

Locations

AR(1)