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

CLINICAL TRIAL, SINGLE BLIND, RANDOMIZED, CONTROLLED PROSPECTIVE EVALUATION FOR OPTIMUM TIME INTERVAL BETWEEN ACETATE ADMINISTRATION AND PUNCTURE TRIPTORELIN FOLLICULAR IN IVF TREATMENT

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005571-14-ES

Enrollment

176

Registered

2013-06-25

Start date

2013-08-02

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

INFERTILITY

Interventions

Trade Name: DECAPEPTYL Product Name: DECAPEPTYL Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: TRIPTORELIN ACETATE CAS Number: 140194-24-7 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

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 5 and 6 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Identify the optimal time interval between administration of the GnRH analogue 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 triptorelin. Comparing the time interval between protocols optimum hCG and GnRHa. Evaluate the results achieved with the protocols of ovulation induction with GnRHa in IVF treatments and compare them with those obtained with the induction of ovulation with hCG. Assess overall response achieved with the protocol of ovulation induction with GnRHa. Evaluate and compare the sonographic criteria for ovulation induction in ultrasound in 2 and 3 dimensions. Compare and EGF hormone levels between follicles containing mature and immature oocytes induced cycles between GnRHa and hCG	—

Measure

Time frame

Main Objective: Identify the optimal time interval between administration of the GnRH analogue 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 triptorelin. Comparing the time interval between protocols optimum hCG and GnRHa. Evaluate the results achieved with the protocols of ovulation induction with GnRHa in IVF treatments and compare them with those obtained with the induction of ovulation with hCG. Assess overall response achieved with the protocol of ovulation induction with GnRHa. Evaluate and compare the sonographic criteria for ovulation induction in ultrasound in 2 and 3 dimensions. Compare and EGF hormone levels between follicles containing mature and immature oocytes induced cycles between GnRHa and hCG

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Secondary

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

Measure

Time frame

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

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Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACION SANITARIA LA FE

investigacion_clinica@iislafe.es34961246611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026