Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval

NCT ID: NCT02244151

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-02-02

Brief Summary

The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles.

Detailed Description

Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades. When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.

From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h). However, differences exist regarding the duration and profile of the GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and hCG trigger.

No previous randomized controlled trials have been reported to evaluate the optimal interval of time between ovulation induction by GnRHa and oocyte collection.

The present study compares the ovarian response and the IVF outcomes after induction by triptorelin 0.2 mg at four different time intervals:

Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU 36 hours after GnRHa administration.

Conditions

Female Urogenital Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DECAPEPTYL® diario

Group 1: DECAPEPTYL® diario,OPU 24 hours after GnRHa administration.

Group Type: EXPERIMENTAL

Decapeptyl® diario

Intervention Type: DRUG

Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.

Decapeptyl® diaro

Group 2:Decapeptyl® diario OPU 30 hours after GnRHa administration.

Group Type: EXPERIMENTAL

Decapeptyl® diario

Intervention Type: DRUG

Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.

Decapeptyl® diario.

Group 3: Decapeptyl® diario, OPU 40 hours after GnRHa administration.

Group Type: EXPERIMENTAL

Decapeptyl® diario

Intervention Type: DRUG

Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.

Decapeptyl® daily

Group 4: Decapeptyl® daily OPU 36 hrs after GnRH administration

Group Type: ACTIVE_COMPARATOR

Decapeptyl® daily

Intervention Type: DRUG

Decapeptyl® daily OPU 36 hrs after GnRH administration

Interventions

Decapeptyl® diario

Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.

Intervention Type: DRUG

Decapeptyl® daily

Decapeptyl® daily OPU 36 hrs after GnRH administration

Intervention Type: DRUG

Other Intervention Names

Decapeptyl® daily; GnRHa; Decapeptyl® diario; GnRHa

Eligibility Criteria

Inclusion Criteria

• Signed informed consent prior to carry out any procedure associated with the clinical trial.
• Women between 18 and 37 years of age at the time of randomization (both ages included).

Basal serum levels of FSH <10 mIU /ml.

• Serum AMH > 5 to <45 pmol / l.
• Antral follicle count > 6 and < 24.
• Vaginal ultrasound documenting correct visualization of both ovaries and the absence of significant ovarian pathology.
• Short stimulation protocol with GnRH antagonist and conventional dose for ovarian stimulation with 225-300 UI of rhFSH.
• Number of follicles ≥ 16 mm > 5 on the ovulation induction day.

Exclusion Criteria

• Presence of severe endometriosis (Grade III-IV).
• Absence of one ovary due to previous surgery.
• Presence of significant uterine pathology (submucous myomas, endometrial polyp, malformations..)
• Diagnosis of polycystic ovary syndrome (defined according to the Rotterdam criteria).
• History of previous poor response to conventional ovarian stimulation protocols (< 3 MII oocytes or canceled cycle)
• Severe male factor ( TMS< 1 million).
• Participation in another RCT within the past one year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alicia Marzal, M.D

Role: PRINCIPAL_INVESTIGATOR

Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain

César Díaz-García, M.D

Role: STUDY_CHAIR

Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain

Antonio Pellicer, Professor

Role: STUDY_DIRECTOR

Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain.

Locations

Instituto de Investigacion Sanitaria La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

2012-005571-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TIMING

Identifier Type: -

Identifier Source: org_study_id