The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis

NCT01581359 | Completed Phase 4 DMC

• 2 other identifiers: ENDOFIV-0102010-022216-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the administration of an analogue of gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy rate in patients with endometriosis/ endometriomas.

Conditions

Endometriosis; Infertility

Keywords

Endometriosis; GnRH treatment; Infertility; IVF

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate by started cycle

  Number of pregnancies with fetal hearth beat on ultrasound exam divided by total number of started cycle

  2 weeks after biochemical diagnosis of pregnancy

Secondary Outcomes (10)

• Number of oocytes retrieved, total and metaphase II

  In the moment of oocyte retrieval

• Embryo quality

  Two-three days after oocyte recovery and IVF

• Number and size of endometrioma(s)

  Day of the Basal ultrasound

• Rate of pregnancy to term in patients with endometriosis / endometriomas

  37 weeks after cycle

• Miscarriage rate

  22nd week of pregnancy

Study Arms (2)

GnRHa

ACTIVE COMPARATOR

Triptorelin acetate 3,75 mg subcutaneous injection administered on days 1, 28 and 56 after menstrual cycle.

Drug: Triptorelin acetate

Physiological serum

PLACEBO COMPARATOR

physiological serum subcutaneous injection with same delivery device and same volume that active comparator ) administered on days 1, 28 and 56 after menstrual cycle.

Drug: Triptorelin acetate

Interventions

Triptorelin acetate DRUG

* Triptorelin acetate Dosing regimen: 1 subcutaneous injection of 3,75 mg/28 days, total of 3 doses * Placebo Dosing regimen: subcutaneous injection of the same volume of physiological serum/28 days, total of 3 doses

Also known as: Gonapeptyl Depot 3,75

GnRHa; Physiological serum

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \< 28 Kg/m2
• Age \< 40 years old
• Signed informed consent to perform IVF and participation in this study

You may not qualify if:

• Follicle stimulating hormone (FSH) 2nd-5th cycle day \> 12 IU/L
• Liver disease (sALAT\> 80 IU/L)
• Kidney disease (creatinine \> 130 nmol/L)
• Other relevant disease that contraindicates a pregnancy

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Human Reproduction Unit of the La Fe University and Politechnic Hospital

Valencia, Valencia, 46026, Spain

Location

Related Publications (53)

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MeSH Terms

Conditions

Endometriosis; Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• ANA Mª MONZÓ, MD, PhD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2014-04

Locations

ES (1)