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| Name | Class |
|---|---|
| University of Valencia | OTHER |
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This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.
This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.
In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.
The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).
This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH-ant | Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration. |
| |
| GnRH-a | GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) | Drug | 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy and implantation rates | "at 7 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| age of the recipients, body mass index, days undergoing oestrogen therapy | "at 1 mounth" |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an indication for oocyte donation with functioning ovaries.
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| Name | Affiliation | Role |
|---|---|---|
| Raga Francisco, M.D., Ph.D. | Centro Ginecologia y Obstetricia. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEGIOB | Valencia | Valencia | 46004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10770169 | Background | Casan EM, Raga F, Bonilla-Musoles F, Polan ML. Human oviductal gonadotropin-releasing hormone: possible implications in fertilization, early embryonic development, and implantation. J Clin Endocrinol Metab. 2000 Apr;85(4):1377-81. doi: 10.1210/jcem.85.4.6503. | |
| 10433230 | Background | Raga F, Casan EM, Kruessel J, Wen Y, Bonilla-Musoles F, Polan ML. The role of gonadotropin-releasing hormone in murine preimplantation embryonic development. Endocrinology. 1999 Aug;140(8):3705-12. doi: 10.1210/endo.140.8.6899. |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D007987 | Gonadotropin-Releasing Hormone |
| C061018 | ganirelix |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| GnRH antagonist (Orgalutran®) | Drug | GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration. |
|
|
| 10333357 | Background | Casan EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9. doi: 10.1093/molehr/5.3.234. |
| 10022430 | Background | Raga F, Casan EM, Wen Y, Huang HY, Bonilla-Musoles F, Polan ML. Independent regulation of matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), and TIMP-3 in human endometrial stromal cells by gonadotropin-releasing hormone: implications in early human implantation. J Clin Endocrinol Metab. 1999 Feb;84(2):636-42. doi: 10.1210/jcem.84.2.5464. |
| 9716567 | Background | Raga F, Casan EM, Kruessel JS, Wen Y, Huang HY, Nezhat C, Polan ML. Quantitative gonadotropin-releasing hormone gene expression and immunohistochemical localization in human endometrium throughout the menstrual cycle. Biol Reprod. 1998 Sep;59(3):661-9. doi: 10.1095/biolreprod59.3.661. |
| 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 |