NCT03527823

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

April 25, 2018

Last Update Submit

June 18, 2020

Conditions

Fertilization in Vitro

Keywords

Fertilization in VitroGranulosa CellsApoptosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

LH supplementation

luteinizing hormone administrated microdose flare up GnRH analog protocol in poor ovarian responders undergoing in vitro fertilization.

without LH supplementation

microdose flare up GnRH analog protocol in poor ovarian responders

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale population in reproductive age undergoing infertility treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

18-49 aged females who undergoes IVF treatment and who are defined as poor responders

You may qualify if:

  • aged female
  • poor ovarian responders
  • undergoing treatment for primary/secondary infertility

You may not qualify if:

  • endocrinologic or metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sebnem Alanya Tosun

Giresun, Turkey (Türkiye)

Location

Related Publications (9)

  • Bosch E, Labarta E, Crespo J, Simon C, Remohi 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.

    PMID: 21067717BACKGROUND

  • 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. doi: 10.1016/j.fertnstert.2004.06.041.

    PMID: 15589853BACKGROUND

  • Kaleli S, Yanikkaya-Demirel G, Erel CT, Senturk LM, Topcuoglu 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. doi: 10.1016/j.fertnstert.2005.02.040.

    PMID: 16169431BACKGROUND

  • 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. doi: 10.1210/jcem.84.1.5389.

    PMID: 9920089BACKGROUND

  • 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. doi: 10.1093/humupd/8.6.543.

    PMID: 12498424BACKGROUND

  • Balasch J, Vidal E, Penarrubia J, Casamitjana R, Carmona F, Creus M, Fabregues 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. doi: 10.1093/humrep/16.8.1636.

    PMID: 11473955BACKGROUND

  • 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. doi: 10.1002/14651858.CD005070.pub2.

    PMID: 17443569BACKGROUND

  • 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. doi: 10.1093/humrep/dei293. Epub 2005 Sep 19.

    PMID: 16172149BACKGROUND

  • 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. doi: 10.1093/humrep/deh625. Epub 2004 Dec 2.

    PMID: 15576390BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

folicular aspiration fluid sampling

Study Officials

  • enis ozkaya

    zeynep kamil education and research hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor- Obstetrics and Gynaecology

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 17, 2018

Study Start

October 17, 2018

Primary Completion

December 1, 2018

Study Completion

January 10, 2019

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations

TU(1)