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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022216-39 | EudraCT Number |
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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.
Endometriosis is defined as the presence of ectopic endometrial tissue which induces a local inflammatory reaction. Usually, this tissue is located at any level in the pelvic region, but extrapelvic locations have been described. It is a chronic disease whose cause is unknown, although a genetic predisposition has been proven. It is estimated that endometriosis affects 7-15% of women of fertile age, and up to 30-40% of women with endometriosis have infertility.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRHa | Active Comparator | Triptorelin acetate 3,75 mg subcutaneous injection administered on days 1, 28 and 56 after menstrual cycle. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin acetate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved, total and metaphase II | In the moment of oocyte retrieval | |
| Embryo quality |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ANA Mª MONZÓ, MD, PhD | Hospital Universitario La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Reproduction Unit of the La Fe University and Politechnic Hospital | Valencia | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3091408 | Background | Matson PL, Yovich JL. The treatment of infertility associated with endometriosis by in vitro fertilization. Fertil Steril. 1986 Sep;46(3):432-4. doi: 10.1016/s0015-0282(16)49581-6. | |
| 8046030 | Background | Simon C, Gutierrez A, Vidal A, de los Santos MJ, Tarin JJ, Remohi J, Pellicer A. Outcome of patients with endometriosis in assisted reproduction: results from in-vitro fertilization and oocyte donation. Hum Reprod. 1994 Apr;9(4):725-9. doi: 10.1093/oxfordjournals.humrep.a138578. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 19, 2020 | |
| Reset | Sep 4, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 19, 2020 | Sep 4, 2020 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| Two-three days after oocyte recovery and IVF |
| Number and size of endometrioma(s) | Total number in each ovary, uni or bilateral cysts and maximum diameter (mm) of the biggest endometrioma | Day of the Basal ultrasound |
| Rate of pregnancy to term in patients with endometriosis / endometriomas | Number of deliveries at 37th to 41st weeks of pregnancy divided by total number of pregnancies | 37 weeks after cycle |
| Miscarriage rate | Number of pregnancy losses divided by total number clinical pregnancies | 22nd week of pregnancy |
| Rate of healthy and live births | Number of healthy and live births divided by total number of started cycle | 37th to 41st weeks of pregnancy |
| Fertilization rate | Number of cleavage embryos divided by total number of metaphase II oocytes | Two days after oocyte recovery and IVF |
| Total dose of gonadotropins and days of treatment | Total dose of gonadotropins in IU, and total days on treatment | Day of the administration of human chorionic gonadotropin (hCG) |
| Cancellation rate and causes | Number of cancelled cycles divided by total number or started cycles | Last day of gonadotropin treatment |
| Ovarian Hyperstimulation Syndrome (OHSS) incidence | Number of patients diagnosed of OHSS divided by ended cycles. Classification in mild, moderate and severe | One month after hCG |
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| D000091662 | Genital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |