NCT04846218

Brief Summary

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

December 31, 2016

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy diagnosed by pregnancy test and ultrasound

    1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Drug: hCGDrug: Triptorelin

Group 2

ACTIVE COMPARATOR

They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Drug: hCGDrug: Progesterone

Interventions

hCGDRUG
Group 1Group 2
Also known as: Prontogest
Group 2
Also known as: Decapeptyl
Group 1

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 39 years.
  • Body mass index between 18 and 30.
  • Unexplained infertility or male factor infertility

You may not qualify if:

  • Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
  • More than 2 previous attemptsof IVF
  • Any uterine anatomical anomaly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams Maternity Hospital

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

ProgesteroneTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 31, 2016

First Posted

April 15, 2021

Study Start

December 1, 2016

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations