The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis
NCT ID: NCT01581359
Last Updated: 2015-10-22
Study Results
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Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2012-03-31
2015-05-31
Brief Summary
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Detailed Description
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Assisted reproduction techniques (ART) are the treatment of many causes of infertility, including endometriosis. The results of assisted reproduction in women with endometriosis appear to be somewhat worse than those obtained from women without endometriosis. Some authors have proven a significant reduction in implantation and pregnancy rates in these patients.
The worst pregnancy rate and implantation is believed to be originated in a poor oocyte quality, which can lead to a lower rate of fertilization. This poor oocyte quality produce poorer quality embryos with a reduced capacity to implant, particularly in severe endometriosis.
On the other hand, endometrial receptivity does not appear to contribute to the reduction of results of ART in these women.
In an attempt to improve ART outcomes in women with endometriosis, different strategies have been proposed prior to the cycle realization, with different results.
Surgical resection of endometriomas (endometriosis cysts) before the cycle of IVF/ICSI may adversely affect the results. On the other hand, careful laparoscopic cystectomy appears not to affect the ovarian response to stimulation.
In addition to surgical approaches, have been tried different medical treatments to improve the results of IVF / intracytoplasmatic sperm injection (ICSI) in women with endometriosis. It has been suggested that treatment with Danazol prior to IVF may improve results. Similarly, prolonged treatment with GnRH analogues few months before IVF could improve the implantation and pregnancy rates. Unfortunately, many of these studies were not randomized and / or controlled so that the true value of therapy with GnRH analogues before IVF in women with endometriosis still needs to be valued. A recent meta-analysis showed that a 3-6 month treatment with GnRH analogues before IVF increased 4 times the odds of clinical pregnancy in women with endometriosis. Nevertheless, these results were concluded from 165 patients and 78 pregnancies, included in 3 clinical trials, which was not specifically to patients with endometriomas.
The lack of studies with proper design, suggests that there is insufficient evidence at present to establish firm recommendations in this regard. This study will contribute to increasing scientific evidence to recommend or not pretreatment with GnRH agonists before IVF en patients with endometriosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GnRHa
Triptorelin acetate 3,75 mg subcutaneous injection administered on days 1, 28 and 56 after menstrual cycle.
Triptorelin acetate
* 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
Physiological serum
physiological serum subcutaneous injection with same delivery device and same volume that active comparator ) administered on days 1, 28 and 56 after menstrual cycle.
Triptorelin acetate
* 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
Interventions
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Triptorelin acetate
* 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \< 28 Kg/m2
* Age \< 40 years old
* Signed informed consent to perform IVF and participation in this study
Exclusion Criteria
* Liver disease (sALAT\> 80 IU/L)
* Kidney disease (creatinine \> 130 nmol/L)
* Other relevant disease that contraindicates a pregnancy
18 Years
40 Years
FEMALE
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Principal Investigators
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ANA Mª MONZÓ, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Locations
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Human Reproduction Unit of the La Fe University and Politechnic Hospital
Valencia, Valencia, Spain
Countries
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References
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Other Identifiers
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2010-022216-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ENDOFIV-010
Identifier Type: -
Identifier Source: org_study_id
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