NCT01790282

Brief Summary

Study if supporting luteal phase of high responder (high egg production or high Estradiol level) long Gn\_Rh agonist protocol ICSI/IVF cycle by combined Estradiol and progesterone impairs or improves outcome in terms of pregnancy and implanation rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

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

February 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

February 8, 2013

Last Update Submit

June 14, 2022

Conditions

IVFInfertility

Keywords

luteal supporthigh responderICSIcycle outcome

Outcome Measures

Primary Outcomes (1)

  • cycle pregnancy rate

    pregnancy rate per started cycle

    6 weeks

Secondary Outcomes (1)

  • implantation rate, multiple pregnancy rate, ongoing pregnancy rate ,live birth rate

    6 weeks

Study Arms (2)

estradiole - progesterone arm

EXPERIMENTAL

Cases are given estradiole valerate 2mg 3 times /day from day of ovum pick up until the time of pregnancy test two weeks together with daily IM injection of 100 progesterone starting . Single intramuscular 0.1 mg decapeptyl are given on day of transfer

Drug: estradiol plus progesterone 100 mg IM injectionDrug: Progesterone IM of 100 mg

Progesterone only arm

ACTIVE COMPARATOR

Patient are given 100 mg progesterone daily starting on day of pickup plus single dose of decapeptyl 0.1 mg on day of embryo transfer

Drug: Progesterone IM of 100 mg

Interventions

estradiol plus progesterone 100 mg IM injectionDRUG

estradile valaerate 2mg plus progesterone 100 mg/day support arm :E2 valerate 2mg three times /day are given to the arm cases plus P4 100 IM/day for 14 days starting on day of ovum pickup and single IM injection of 0.1 mg decapeptyl on day of ET

Also known as: estradiole valerate 2mg,, Prontogest 100 mg
estradiole - progesterone arm
Progesterone IM of 100 mgDRUG

Starting on day of ovum pickup ICSI cases are given prontogest 100 mg IM /day plus single dose dose of treptorline 0.1mg is given sc on day of embryo transfer

Also known as: prontogest 100 mg ampoles
Progesterone only armestradiole - progesterone arm

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age\<40 years,
  • first ICSI cycle,
  • third day FSH\< 10 mIU/mL,
  • serum E2 level on day of hCG administration \<4,000 pg/mL,
  • number of ova obtained \>15

You may not qualify if:

  • age 40 years or more,
  • basal FSH 10 mIU/mL or more ,
  • eggs retrieved 15 or less ,
  • E2 level on day of hCG administration 4000 or more pg/ mL or more,
  • repeat ICSI , need for PGD, presence of myoma , hydrosalpinx (unless disconnected)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Integrated fertility center

Al Mansurah, Dekahlia, Egypt

Location

Related Publications (2)

  • Gelbaya TA, Kyrgiou M, Tsoumpou I, Nardo LG. The use of estradiol for luteal phase support in in vitro fertilization/intracytoplasmic sperm injection cycles: a systematic review and meta-analysis. Fertil Steril. 2008 Dec;90(6):2116-25. doi: 10.1016/j.fertnstert.2007.10.053. Epub 2008 Jan 7.

    PMID: 18178194BACKGROUND

  • Sunkara SK, Rittenberg V, Raine-Fenning N, Bhattacharya S, Zamora J, Coomarasamy A. Association between the number of eggs and live birth in IVF treatment: an analysis of 400 135 treatment cycles. Hum Reprod. 2011 Jul;26(7):1768-74. doi: 10.1093/humrep/der106. Epub 2011 May 10.

    PMID: 21558332BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

EstradiolProgesteroneInjections, Intramuscular

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone CongenersInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 13, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

EG(1)