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Trial · Observational

CompletedPhase not statedRegistry data

Luteal Phase Support In IVF Women Using GnRH Agonist

NCTNCT04174378 (opens ClinicalTrials.gov in a new tab)Other idPPI/111/8/JEP-2018-619
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
222 participants (actual)
Sponsor
National University of Malaysia · Other
Design
Not stated
Countries
1 country

Malaysia

Start
29 Nov 2018
Primary completion
28 Aug 2019
Completion
18 Nov 2019
First posted
22 Nov 2019
Last update posted
25 Nov 2019
Conditions
IVF · Luteal Phase Defect

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph –

    Luteal Phase Support In IVF Women Using GnRH Agonist

    NCT04174378

    29 Nov 2018 to 18 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Lately, the role of GnRH agonist as luteal phase support has been recommended by various studies though the mechanism is still debatable. It has been postulated that GnRH agonist might support the corpus luteum by stimulating the secretion of luteinizing hormone by pituitary gonadotroph cells, or by acting directly on the endometrium through the locally expressed receptors. Therefore, this study was designed to evaluate effects of the additional of single-dose GnRH agonist to the routine progestogens use for luteal phase support on IVF outcome as compared to progestogens only. The biochemical pregnancy rates, clinical pregnancy rates, live birth rates and miscarriage rate between these regimes were compared. The hypothesis of this study was women with addition of GnRH agonist as luteal phase support have higher biochemical pregnancy rate, clinical pregnancy rate and live birth rate compare to patient with progestogens only luteal phase support.

Interventions

  • Decapeptyl 0.2mgDrug

Arms2

  • Other

    GnRH agonist with progestogen support

  • Other

    progestogen support only

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Biochemical pregnancy rate

    Time frame · 14 days after embryo transfer

    Registry description

    serum B-HCG more than 5 mIU/ml

  2. clinical pregnancy rate

    Time frame · 4 weeks after embryo transfer

    Registry description

    presence of gestational sac

  3. live birth rate

    Time frame · beyond 24 weeks of gestation

    Registry description

    gestation more than 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2019

5 results

The addition of single dose GnRH agonist to luteal phase support in artificial cycle frozen embryo transfer: a randomized clinical trial.

Ye et al. 2019Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinologycited by 14

PMID 30700175DOI 10.1080/09513590.2018.1563888PUB-30700175

Full text at the publisher5 results
Publisher pageSee results (5)

PubMed tag: none · 2015

2 results

Effects of single dose GnRH agonist as luteal support on pregnancy outcome in frozen-thawed embryo transfer cycles: an RCT.

Davar et al. 2015Iranian journal of reproductive medicinecited by 15

PMID 26568750PMC4637112PUB-26568750

CC BY2 results
Download PDFSee results (2)

Indexing hint: Randomized controlled trial · 2009

2 results

Beneficial effect of luteal-phase gonadotropin-releasing hormone agonist administration on implantation rate after intracytoplasmic sperm injection.

Razieh et al. 2009Taiwanese journal of obstetrics & gynecologycited by 27

PMID 19797013DOI 10.1016/s1028-4559(09)60297-7PUB-19797013

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2006

6 results

Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.

Tesarik et al. 2006Human reproduction (Oxford, England)cited by 89

PMID 16926261DOI 10.1093/humrep/del173PUB-16926261

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Clinical trial · 2004

6 results

Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation.

Tesarik et al. 2004Human reproduction (Oxford, England)cited by 84

PMID 15070873DOI 10.1093/humrep/deh235PUB-15070873

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

2 studies on this page

PubMed tag: none · 2014

Luteal phase support with decapeptyl improves pregnancy outcomes in intracytoplasmic sperm injection with higher basal follicle-stimulating hormone or lower mature oocytes.

Kung et al. 2014Journal of the Chinese Medical Association : JCMAcited by 12

PMID 25160805DOI 10.1016/j.jcma.2014.07.001PUB-25160805

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2008

Corrected

Luteal phase support with GnRH-a improves implantation and pregnancy rates in IVF cycles with endometrium of <or=7 mm on day of egg retrieval.

Qublan et al. 2008Human fertility (Cambridge, England)cited by 33

PMID 18320439DOI 10.1080/14647270701704768PUB-18320439

Full text at the publisher
Publisher pageRead the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBeckers NG, Macklon NS, Eijkemans MJ, Ludwig M, Felberbaum RE, Diedrich K, Bustion S, Loumaye E, Fauser BC. Nonsupplemented luteal phase characteristics after the administration of recombinant human chorionic gonadotropin, recombinant luteinizing hormone, or gonadotropin-releasing hormone (GnRH) agonist to induce final oocyte maturation in in vitro fertilization patients after ovarian stimulation with recombinant follicle-stimulating hormone and GnRH antagonist cotreatment. J Clin Endocrinol Metab. 2003 Sep;88(9):4186-92. doi: 10.1210/jc.2002-021953. PMID 12970285
  • ResultKolibianakis EM, Bourgain C, Platteau P, Albano C, Van Steirteghem AC, Devroey P. Abnormal endometrial development occurs during the luteal phase of nonsupplemented donor cycles treated with recombinant follicle-stimulating hormone and gonadotropin-releasing hormone antagonists. Fertil Steril. 2003 Aug;80(2):464-6. doi: 10.1016/s0015-0282(03)00663-0. No abstract available. PMID 12909519
  • ResultSmitz J, Bourgain C, Van Waesberghe L, Camus M, Devroey P, Van Steirteghem AC. A prospective randomized study on oestradiol valerate supplementation in addition to intravaginal micronized progesterone in buserelin and HMG induced superovulation. Hum Reprod. 1993 Jan;8(1):40-5. doi: 10.1093/oxfordjournals.humrep.a137871. PMID 8458924
  • ResultPritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287. PMID 12202415
  • ResultDupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m. PMID 2161310
  • ResultZafardoust S, Jeddi-Tehrani M, Akhondi MM, Sadeghi MR, Kamali K, Mokhtar S, Badehnoosh B, Arjmand-Teymouri F, Fatemi F, Mohammadzadeh A. Effect of Administration of Single Dose GnRH Agonist in Luteal Phase on Outcome of ICSI-ET Cycles in Women with Previous History of IVF/ICSI Failure: A Randomized Controlled Trial. J Reprod Infertil. 2015 Apr-Jun;16(2):96-101. PMID 25927026
  • ResultAta B, Urman B. Single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles: is the effect dependent on the type of GnRH analogue used for pituitary suppression? Reprod Biomed Online. 2010 Jan;20(1):165-6; author reply 167. doi: 10.1016/j.rbmo.2009.10.022. Epub 2009 Nov 10. No abstract available. PMID 20159003
  • ResultAta B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12. PMID 18192671
  • ResultBenmachiche A, Benbouhedja S, Zoghmar A, Boularak A, Humaidan P. Impact of Mid-Luteal Phase GnRH Agonist Administration on Reproductive Outcomes in GnRH Agonist-Triggered Cycles: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2017 Jun 15;8:124. doi: 10.3389/fendo.2017.00124. eCollection 2017. PMID 28663739
  • ResultPirard C, Donnez J, Loumaye E. GnRH agonist as novel luteal support: results of a randomized, parallel group, feasibility study using intranasal administration of buserelin. Hum Reprod. 2005 Jul;20(7):1798-804. doi: 10.1093/humrep/deh830. Epub 2005 May 12. PMID 15890740
  • ResultPirard C, Donnez J, Loumaye E. GnRH agonist as luteal phase support in assisted reproduction technique cycles: results of a pilot study. Hum Reprod. 2006 Jul;21(7):1894-900. doi: 10.1093/humrep/del072. Epub 2006 Mar 23. PMID 16556673
  • ResultFujii S, Sato S, Fukui A, Kimura H, Kasai G, Saito Y. Continuous administration of gonadotrophin-releasing hormone agonist during the luteal phase in IVF. Hum Reprod. 2001 Aug;16(8):1671-5. doi: 10.1093/humrep/16.8.1671. PMID 11473961

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * underwent ICSI * given progestogens plus GnRH agonist or progestogens only as luteal phase support. Exclusion Criteria: * different luteal phase support * frozen embryo transfer and * missing medical records data

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