NCT04749979

Brief Summary

Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 29, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

January 29, 2021

Last Update Submit

February 10, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • the number of good quality embryos

    how many good quality embryos

    within 5 months

Study Arms (2)

giving agonist ( eg. decapeptyl )

ACTIVE COMPARATOR

Giving women agonist

Drug: Agonist (decapeptyl )

Giving HCG (eg. choriomon )

ACTIVE COMPARATOR

Giving women HCG

Drug: HCG ( eg. Choriomon )

Interventions

Agonist (decapeptyl )DRUG

giving agonist

giving agonist ( eg. decapeptyl )
HCG ( eg. Choriomon )DRUG

giving HCG

Giving HCG (eg. choriomon )

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales candidate for ICSI
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS patients according to Rotterdam criteria
  • Female age between 20 and 40 years.
  • Primary or secondary infertility.
  • Body mass index (BMI) between 18 and 40 kg/m2.

You may not qualify if:

  • Ovarian endometriosis.
  • Ovarian cysts before induction.
  • Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 11, 2021

Study Start

February 5, 2021

Primary Completion

June 25, 2021

Study Completion

July 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

EG(1)