NCT02825290

Brief Summary

This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

July 3, 2016

Last Update Submit

December 11, 2016

Conditions

Embryo TransferLuteal Support

Keywords

Frozen-thawed embryo transfer (FET)Luteal supportProgesteroneNatural cycleCryopreservationIVFhCGGnRH-AgonistPregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    Number of viable pregnancies at about 10-12 weeks of gestation.

    About 10-12 weeks after embryo transfer

Secondary Outcomes (2)

  • Implantation rate

    2 weeks after embryo transfer

  • Clinical pregnancy

    About 3-4 weeks after embryo transfer

Study Arms (2)

Study group

EXPERIMENTAL

hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer \& GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support.

Drug: Choriogonadotropin alfaDrug: Triptorelin acetate

Control group

NO INTERVENTION

The usual progesterone only luteal phase support.

Interventions

Choriogonadotropin alfaDRUG
Also known as: recombinant hCG, Ovitrelle, Ovidrel
Study group
Triptorelin acetateDRUG
Also known as: GnRH-Agonist, Decapeptyl
Study group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old women
  • Spontaneously ovulating women
  • Treated in our IVF unit for frozen-thawed embryo transfer
  • At least one top quality embryo

You may not qualify if:

  • PGD patients
  • More than 4 previous embryo transfers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

Related Publications (13)

  • Thurin A, Hausken J, Hillensjo T, Jablonowska B, Pinborg A, Strandell A, Bergh C. Elective single-embryo transfer versus double-embryo transfer in in vitro fertilization. N Engl J Med. 2004 Dec 2;351(23):2392-402. doi: 10.1056/NEJMoa041032.

    PMID: 15575055BACKGROUND

  • Le Lannou D, Griveau JF, Laurent MC, Gueho A, Veron E, Morcel K. Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI. Reprod Biomed Online. 2006 Sep;13(3):368-75. doi: 10.1016/s1472-6483(10)61441-1.

    PMID: 16984767BACKGROUND

  • Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Clinical rationale for cryopreservation of entire embryo cohorts in lieu of fresh transfer. Fertil Steril. 2014 Jul;102(1):3-9. doi: 10.1016/j.fertnstert.2014.04.018. Epub 2014 May 17.

    PMID: 24842675BACKGROUND

  • Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.

    PMID: 21737072BACKGROUND

  • Orvieto R, Fisch B, Feldberg D. Endometrial Preparation for Patients undergoing Frozen- Thawed Embryo Transfer Cycles. In: The Art & Science of Assisted Reproductive Techniques. G. Allahbadia, R. asuray, R. Merchant, Eds. Jaypee Brothers Medical Publishers (P) Ltd. New Delhi, India, 2003, pp. 396-9.

    BACKGROUND

  • Navot D, Laufer N, Kopolovic J, Rabinowitz R, Birkenfeld A, Lewin A, Granat M, Margalioth EJ, Schenker JG. Artificially induced endometrial cycles and establishment of pregnancies in the absence of ovaries. N Engl J Med. 1986 Mar 27;314(13):806-11. doi: 10.1056/NEJM198603273141302.

    PMID: 3951513BACKGROUND

  • Pritts 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: 12202415BACKGROUND

  • Meldrum DR. Female reproductive aging--ovarian and uterine factors. Fertil Steril. 1993 Jan;59(1):1-5. doi: 10.1016/s0015-0282(16)55608-8.

    PMID: 8419194BACKGROUND

  • Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

    PMID: 20097333BACKGROUND

  • Tesarik J, Hazout A, Mendoza C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Hum Reprod. 2004 May;19(5):1176-80. doi: 10.1093/humrep/deh235. Epub 2004 Apr 7.

    PMID: 15070873BACKGROUND

  • 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: 16926261BACKGROUND

  • Orvieto R, Brengauz M, Feldman B. A novel approach to normal responder patient with repeated implantation failures--a case report. Gynecol Endocrinol. 2015 Jun;31(6):435-7. doi: 10.3109/09513590.2015.1005595. Epub 2015 Mar 3.

    PMID: 25731193BACKGROUND

  • Haas J, Lantsberg D, Feldman N, Manela D, Machtinger R, Dar S, Rabinovici J, Orvieto R. Modifying the luteal phase support in natural cycle frozen-thawed embryo transfer improves cycle outcome. Gynecol Endocrinol. 2015;31(11):891-3. doi: 10.3109/09513590.2015.1075502. Epub 2015 Aug 18.

    PMID: 26288149BACKGROUND

MeSH Terms

Interventions

Chorionic GonadotropinOvidrelTriptorelin PamoateGonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsPituitary Hormone-Releasing HormonesHypothalamic HormonesNeuropeptidesOligopeptidesNerve Tissue Proteins

Central Study Contacts

Eran Zilberberg, MD

CONTACT

+97235302882eran.zilberberg@gmail.com

Raoul Orvieto, MD

CONTACT

+97235302882

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)