Fertilization in Vitro Clinical Trial
Official title:
The Comparison of Granulosa Cell Apoptosis Rates on Microdose Flare up GnRH Analog Protocol Versus Luteinizing Hormone Administrated Microdose Flare up GnRH Analog Protocol in Poor Ovarian Responders Undergoing in Vitro Fertilization.
Verified date | June 2020 |
Source | Giresun University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
In Zeynep Kamil Women and Children's Education and Research Hospital which is a tertiary
referral hospital, the investigators perform microdose flare-up gonadotropin-releasing
hormone (GNRH) analogue or GNRH antagonist protocol to the poor responders. The investigators
may or may not supplement luteinizing hormone (LH). Human chorionic gonadotropin (hCG)
triggering is performed when at least 2 follicles diameter are above 17 mm and the serum
estradiol level is above 500 pg / ml. 36 hours after hCG, ovarian aspiration is performed by
the guidance of transvaginal ultrasound. Normally after oocyte separation process, the
remaining follicle aspiration fluid is destroyed.
n the present study, the follicle aspiration fluid is planned to be used with the patient's
permission. The investigators are going to examine the granulosa cell apoptosis rate by using
annexin-5 antibody in both groups 1 (LH added) and 2 (without LH).
For this purpose, a total of 40 volunteer patients are planned to involve, the groups are
designed as 20 LH added and 20 LH added women.
In the present study, the investigators hypothesis that the rates of granulosa cell apoptosis
in poor responders may be different between the group 1 (with LH) and group 2 (without LH),
this will lead to IVF therapy in the near future.
Status | Completed |
Enrollment | 31 |
Est. completion date | January 10, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 18-49 aged female - poor ovarian responders - undergoing treatment for primary/secondary infertility Exclusion Criteria: - endocrinologic or metabolic disorders |
Country | Name | City | State |
---|---|---|---|
Turkey | Sebnem Alanya Tosun | Giresun |
Lead Sponsor | Collaborator |
---|---|
Sebnem Alanya Tosun | Giresun University Funding for Scientific Research Project |
Turkey,
Balasch J, Vidal E, Peñarrubia J, Casamitjana R, Carmona F, Creus M, Fábregues F, Vanrell JA. Suppression of LH during ovarian stimulation: analysing threshold values and effects on ovarian response and the outcome of assisted reproduction in down-regulated women stimulated with recombinant FSH. Hum Reprod. 2001 Aug;16(8):1636-43. — View Citation
Bosch E, Labarta E, Crespo J, Simón C, Remohí J, Pellicer A. Impact of luteinizing hormone administration on gonadotropin-releasing hormone antagonist cycles: an age-adjusted analysis. Fertil Steril. 2011 Mar 1;95(3):1031-6. doi: 10.1016/j.fertnstert.2010.10.021. Epub 2010 Nov 10. — View Citation
De Placido G, Alviggi C, Perino A, Strina I, Lisi F, Fasolino A, De Palo R, Ranieri A, Colacurci N, Mollo A; Italian Collaborative Group on Recombinant Human Luteinizing Hormone. Recombinant human LH supplementation versus recombinant human FSH (rFSH) step-up protocol during controlled ovarian stimulation in normogonadotrophic women with initial inadequate ovarian response to rFSH. A multicentre, prospective, randomized controlled trial. Hum Reprod. 2005 Feb;20(2):390-6. Epub 2004 Dec 2. — View Citation
Ferraretti AP, Gianaroli L, Magli MC, D'angelo A, Farfalli V, Montanaro N. Exogenous luteinizing hormone in controlled ovarian hyperstimulation for assisted reproduction techniques. Fertil Steril. 2004 Dec;82(6):1521-6. — View Citation
Filicori M, Cognigni GE, Samara A, Melappioni S, Perri T, Cantelli B, Parmegiani L, Pelusi G, DeAloysio D. The use of LH activity to drive folliculogenesis: exploring uncharted territories in ovulation induction. Hum Reprod Update. 2002 Nov-Dec;8(6):543-57. Review. — View Citation
Kaleli S, Yanikkaya-Demirel G, Erel CT, Senturk LM, Topçuoglu A, Irez T. High rate of aneuploidy in luteinized granulosa cells obtained from follicular fluid in women who underwent controlled ovarian hyperstimulation. Fertil Steril. 2005 Sep;84(3):802-4. — View Citation
Mochtar MH, Van der Veen, Ziech M, van Wely M. Recombinant Luteinizing Hormone (rLH) for controlled ovarian hyperstimulation in assisted reproductive cycles. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005070. Review. Update in: Cochrane Database Syst Rev. 2017 May 24;5:CD005070. — View Citation
Sullivan MW, Stewart-Akers A, Krasnow JS, Berga SL, Zeleznik AJ. Ovarian responses in women to recombinant follicle-stimulating hormone and luteinizing hormone (LH): a role for LH in the final stages of follicular maturation. J Clin Endocrinol Metab. 1999 Jan;84(1):228-32. — View Citation
Tarlatzis B, Tavmergen E, Szamatowicz M, Barash A, Amit A, Levitas E, Shoham Z. The use of recombinant human LH (lutropin alfa) in the late stimulation phase of assisted reproduction cycles: a double-blind, randomized, prospective study. Hum Reprod. 2006 Jan;21(1):90-4. Epub 2005 Sep 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the comparison of granulosa cell apoptosis rate with or without LH supplementation in poor responders | the investigators hypothesized that granulosa cell apoptosis rate on luteinizing hormone supplemented microdose flare up GnRH analog protocol in poor ovarian responders undergoing in vitro fertilization would be lower than not administered protocol | June 2018-August 2018 |
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