NCT02238431

Brief Summary

Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are being cancelled because of premature luteinization, and the treatment (to transfer) takes approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the normal menstrual cycle to determine the time to start the FET cycle may suit some patients. Whether these benefits can be obtained while still maintaining the current FET pregnancy rate will be the main focus of the trial.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

September 5, 2014

Last Update Submit

May 25, 2016

Conditions

Pregnancy

Keywords

Lucrin depot,frozen embryo transfer,artificial cycle,pregnancy,cancellation

Outcome Measures

Primary Outcomes (1)

  • Cycle cancellation

    blood progesterone concentration (\>2nmol/L) as a measure of premature luteinization

    On day 14 of estrogen supplementation

Secondary Outcomes (1)

  • Ongoing pregnancy rate

    20 weeks of gestation

Other Outcomes (1)

  • Pregnancy

    15 days after start the start of progesterone supplementation

Study Arms (3)

Lucrin depot, artificial cycle start

EXPERIMENTAL

intramuscular administration of Lucrin depot (half dose of 3.75mg) on the 5th day following oocyte retrieval

Drug: Lucrin depot

OCP active, artificial cycle start

ACTIVE COMPARATOR

to take active OCP tablets (1 per day) from the 10th day following oocyte retrieval for at least 21 days

Drug: OCP

Natural, menstrual period

EXPERIMENTAL

to wait for the second bleed to commence the artificial FET cycle

Other: Natural

Interventions

Lucrin depotDRUG

scheduling the start of the artificial cycle and hormone down regulation during the artificial cycle

Lucrin depot, artificial cycle start
OCPDRUG

to schedule the start of the artificial cycle

OCP active, artificial cycle start
NaturalOTHER

to use the normal menstrual period to schedule treatment start

Natural, menstrual period

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • If patients have \>2 blastocysts vitrified

You may not qualify if:

  • All patients not willing to participate in the study
  • Patients with any known adverse reaction to one or the other of the drugs prescribed
  • All patients that have no surviving blastocysts for transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya IVF

Antalya, Antalya, 07080, Turkey (Türkiye)

Location

Related Publications (3)

  • Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.

    PMID: 16500326BACKGROUND

  • Hill MJ, Miller KA, Frattarelli JL. A GnRH agonist and exogenous hormone stimulation protocol has a higher live-birth rate than a natural endogenous hormone protocol for frozen-thawed blastocyst-stage embryo transfer cycles: an analysis of 1391 cycles. Fertil Steril. 2010 Feb;93(2):416-22. doi: 10.1016/j.fertnstert.2008.11.027. Epub 2009 Jan 26.

    PMID: 19171338BACKGROUND

  • Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.

    PMID: 23820515RESULT

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Advisor

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 12, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

TU(1)