Trial | NCT01391845  Report issue

Title

Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern
Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ulipristal ...

  • Study Participants

    16
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.
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.

Objective: to evaluate the endometrial effect of Progesterone through Glycodelin-A expression pattern on women exposed or not to ulipristal acetate in GnRH Antagonist cycles using two different doses of FSH for ovarian controlled stimulation.

Methods: prospective controlled randomized study. It will be enrolling 16 oocytes donors from Oocyte Donation Program of PROAR (a Reproductive Center of Rosario, Argentina). On day 3 of menstrual cycle FSH serum levels and antral follicular count (AFC) will be measure. If those results fulfill with inclusions criteria, patients will be randomize for FSH 225UI or 300UI GnRH-Antagonist/ urinary FSH protocol. P serum levels will be measure every 48 hours since at least 1 follicle ≥14 mm will be achieve until at least 1 follicle reach 19mm of diameter. The next day of hCG administration a new P circulating will be measure and then the patient will be randomize trough opaque envelopes for receive 30mg of ulipristal acetate or placebo. An endometrial biopsy with Cornier´s Pipelle will be performing 3 and 5 days after hCG injection (hCG+3 and hCG+5 days) to evaluate endometrial dating and Glycodelin-A expression pattern.

Statistical analysis: nominal variables will be analyzing using t-Student test and the effect of ulipristal with ANOVA.
Study Started
Jul 31
2011
Primary Completion
Mar 31
2012
Anticipated
Study Completion
Jun 30
2012
Anticipated
Last Update
Jul 20
2011
Estimate

Drug ulipristal acetate

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

  • Other names: UPA/FSH 300

Drug placebo

placebo orally in a unique dose the day of hCG injection

  • Other names: No UPA/FSH 300

Drug ulipristal acetate

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

  • Other names: UPA/FSH225

Drug placebo

placebo orally in a unique dose the day of hCG injection

  • Other names: no UPA/FSH225

UPA, 300UI FSH Experimental

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

No UPA, 300FSH Placebo Comparator

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

UPA, FSH 225 Experimental

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

no UPA, FSH225 Placebo Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Hypothyroidism
Hyperprolactinemia
Kidney or liver disease
Smoking
Alcoholism
No Results Posted