Luteal Phase Support In IVF Women Using GnRH Agonist

NCT04174378 | Completed FDA Drug

• 1 other identifier: PPI/111/8/JEP-2018-619
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IVF; Luteal Phase Defect

Keywords

Luteal phase support; GnRH agonist; in vitro fertilization

Outcome Measures

Primary Outcomes (3)

• Biochemical pregnancy rate

  serum B-HCG more than 5 mIU/ml

  14 days after embryo transfer

• clinical pregnancy rate

  presence of gestational sac

  4 weeks after embryo transfer

• live birth rate

  gestation more than 24 weeks

  beyond 24 weeks of gestation

Study Arms (2)

GnRH agonist with progestogen support

Drug: Decapeptyl 0.2mg

progestogen support only

Interventions

Decapeptyl 0.2mg DRUG

IM Decapeptyl o.2 mg was given 2 days before embryo transfer

GnRH agonist with progestogen support

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Data women underwent IVF treatment under MAC (Medically Assisted Conception) Unit, University Kebangsaan Malaysia Medical Centre for the period of June 2015-June 2018 were reviewed.

You may qualify if:

• underwent ICSI
• given progestogens plus GnRH agonist or progestogens only as luteal phase support.

You may not qualify if:

• different luteal phase support
• frozen embryo transfer and
• missing medical records data

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Medically Assisted Conception Unit, UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (24)

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  PMID: 12970285 RESULT

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  PMID: 12202415 RESULT

• Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.

  PMID: 16926261 RESULT

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  PMID: 25927026 RESULT

• Yildiz GA, Sukur YE, Ates C, Aytac R. The addition of gonadotrophin releasing hormone agonist to routine luteal phase support in intracytoplasmic sperm injection and embryo transfer cycles: a randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:66-70. doi: 10.1016/j.ejogrb.2014.08.026. Epub 2014 Aug 27.

  PMID: 25238659 RESULT

• Qublan H, Amarin Z, Al-Qudah M, Diab F, Nawasreh M, Malkawi S, Balawneh M. 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. Hum Fertil (Camb). 2008 Mar;11(1):43-7. doi: 10.1080/14647270701704768.

  PMID: 18320439 RESULT

• Razieh DF, Maryam AR, Nasim T. Beneficial effect of luteal-phase gonadotropin-releasing hormone agonist administration on implantation rate after intracytoplasmic sperm injection. Taiwan J Obstet Gynecol. 2009 Sep;48(3):245-8. doi: 10.1016/S1028-4559(09)60297-7.

  PMID: 19797013 RESULT

• Ata 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 RESULT

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  PMID: 18192671 RESULT

• Kung HF, Chen MJ, Guua HF, Chen YF, Yi YC, Yen-Ping Ho J, Chou MM. Luteal phase support with decapeptyl improves pregnancy outcomes in intracytoplasmic sperm injection with higher basal follicle-stimulating hormone or lower mature oocytes. J Chin Med Assoc. 2014 Oct;77(10):524-30. doi: 10.1016/j.jcma.2014.07.001. Epub 2014 Aug 24.

  PMID: 25160805 RESULT

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  PMID: 15070873 RESULT

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  PMID: 26568750 RESULT

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  PMID: 28663739 RESULT

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  PMID: 15890740 RESULT

• Pirard 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 RESULT

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  PMID: 28228316 RESULT

• Aboulghar MA, Marie H, Amin YM, Aboulghar MM, Nasr A, Serour GI, Mansour RT. GnRH agonist plus vaginal progesterone for luteal phase support in ICSI cycles: a randomized study. Reprod Biomed Online. 2015 Jan;30(1):52-6. doi: 10.1016/j.rbmo.2014.09.017. Epub 2014 Oct 13.

  PMID: 25456166 RESULT

• Chen SL, Wu FR, Luo C, Chen X, Shi XY, Zheng HY, Ni YP. Combined analysis of endometrial thickness and pattern in predicting outcome of in vitro fertilization and embryo transfer: a retrospective cohort study. Reprod Biol Endocrinol. 2010 Mar 24;8:30. doi: 10.1186/1477-7827-8-30.

  PMID: 20334664 RESULT

• Ye H, Luo X, Pei L, Li F, Li C, Chen Y, Zhang X, Huang G. The addition of single dose GnRH agonist to luteal phase support in artificial cycle frozen embryo transfer: a randomized clinical trial. Gynecol Endocrinol. 2019 Jul;35(7):618-622. doi: 10.1080/09513590.2018.1563888. Epub 2019 Jan 31.

  PMID: 30700175 RESULT

MeSH Terms

Interventions

Triptorelin Pamoate

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Muhammad Azrai Abu, Medical Degree

  Department of Obstetrics and Gynecology, UKM Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: November 29, 2018
• Primary Completion: August 28, 2019
• Study Completion: November 18, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)