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

NCT02244151 | Completed Phase 2

• 2 other identifiers: TIMING2012-005571-14
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Urogenital Diseases

Keywords

ovulation induction,oocyte maturation timing and collection

Outcome Measures

Primary Outcomes (4)

• Number of mature oocytes 24 hours post Decapeptyl administration

  The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.

  24 hours post Decapeptyl administration

• Number of mature oocytes 30 hours post Decapeptyl administration

  The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.

  30 hours post Decapeptyl administration

• Number of mature oocytes 36 hours post Decapeptyl administration

  The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.

  36 hours post Decapeptyl administration

• Number of mature oocytes 40 hours post Decapeptyl administration

  The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.

  40 hours post Decapeptyl administration

Secondary Outcomes (4)

• Total number of follicles > 16 mm punctured.

  Time 0 (when Decapeptyl administration)

• Total number of oocytes retrieved

  24, 30, 36 and 40 hours post Decapeptyl administration

• Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin

  24, 30, 36 and 40 hours post Decapeptyl administration

• Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)

  Time 0 (when Decapeptyl administration) , 12 hours after Decapeptyl administration , OPU moment and day of embryo transfer

Study Arms (4)

DECAPEPTYL® diario

EXPERIMENTAL

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

Drug: Decapeptyl® diario

Decapeptyl® diaro

EXPERIMENTAL

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

Drug: Decapeptyl® diario

Decapeptyl® diario.

EXPERIMENTAL

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

Drug: Decapeptyl® diario

Decapeptyl® daily

ACTIVE COMPARATOR

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

Drug: Decapeptyl® daily

Interventions

Decapeptyl® diario DRUG

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

Also known as: Decapeptyl® daily; GnRHa

DECAPEPTYL® diario; Decapeptyl® diario.; Decapeptyl® diaro

Decapeptyl® daily DRUG

Decapeptyl® daily OPU 36 hrs after GnRH administration

Also known as: Decapeptyl® diario; GnRHa

Decapeptyl® daily

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Instituto de Investigacion Sanitaria La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Female Urogenital Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alicia Marzal, M.D

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

  PRINCIPAL INVESTIGATOR

• César Díaz-García, M.D

  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

  STUDY CHAIR

• Antonio Pellicer, Professor

  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.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: September 18, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 2, 2018
• Last Updated: February 15, 2018

Record last verified: 2017-08

Locations

ES (1)