SEARCH THE optimal time interval between ethyl Triptorelin and follicular puncture IN THE TREATMENT OF IN VITRO FERTILIZATIO

Phase 1

• Conditions: INFERTILITY; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-005571-14-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-25
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

Age less than or equal to 37 years. Sterility of tubal origin, unknown or treatable
male factor IVF / ICSI using ejaculated semen (including frozen semen donor).
Blood levels of basal FSH <10 mIU / ml on day 3 of the menstrual cycle. Serum
AMH> 5 and <45 pmol / l Number of antral follicles> 6 and <24 between both
ovaries
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diagnosis of endometriosis severe (Grade III-IV). Diagnosis of SDM. polycystic
ovaries (defined according to the Rotterdam criteria). History of low response in
ovarian stimulation cycles prior defined as presence of less than 4 follicles greater
than 16 mm or canceled cycle. All those patients who do not voluntarily give their
express written consent Known allergy to the drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Identify the optimal time interval between administration of the GnRH analogue<br>triptorelin acetate and needle aspiration of oocytes;Primary end point(s): Number of oocytes at metaphase II;Timepoint(s) of evaluation of this end point: During the puncture.;Secondary Objective: Identify the time necessary for the maturation of the oocyte after administration of<br>triptorelin. Comparing the time interval between protocols optimum hCG and<br>GnRHa. Evaluate the results achieved with the protocols of ovulation induction with<br>GnRHa in IVF treatments and compare them with those obtained with the induction<br>of ovulation with hCG. Assess overall response achieved with the protocol of<br>ovulation induction with GnRHa. Evaluate and compare the sonographic criteria for<br>ovulation induction in ultrasound in 2 and 3 dimensions. Compare and EGF<br>hormone levels between follicles containing mature and immature oocytes induced<br>cycles between GnRHa and hCG

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluate the results achieved with the protocols of ovulation induction<br>with GnRHa in IVF treatments, regarding pregnancy rates achieved.<br>Investigate the relationship between LH levels achieved after<br>administration of triptorelin acetate and the rate of mature oocytes<br>obtained in follicular puncture.<br>Compare and EGF hormone levels between follicles containing mature<br>and immature oocytes between GnRHa induced cycles.;Timepoint(s) of evaluation of this end point: It will determine the pregnancy rate after completing the monitoring of<br>patients, when pregnancy is confirmed clinical trial completion,<br>Transference 30-35 days after the embryo (ET + time 30-35).<br>The determination of serum LH levels were performed at 12<br>postdesencadenamiento ovulation.<br>The collection and processing of follicular fluid will practice at the time<br>of the follicular puncture and aspiration of fluid from the follicles<br>(described in the graph as time P).