NCT04539067

Brief Summary

Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2

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

August 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 25, 2020

Last Update Submit

August 31, 2020

Conditions

Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

  • Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients

    Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients

    9 months

Study Arms (2)

HMG group

EXPERIMENTAL

Induction of ovulation from 2nd day of cycle Follow diameter of follicle When follicle 18:22mm Receive HMG

Drug: HHMG

H FSH plus HHMG

EXPERIMENTAL

Follow up ovulation from the 2nd day to 5th of menstruation cycle When follicle diameter 18mm to 22mm made induction of ovulation

Drug: HHMG

Interventions

HHMGDRUG

Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG

Also known as: Using HHMG for induction
H FSH plus HHMGHMG group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertil women aged from 20\_35yr
  • Normal utreus
  • Normal ovaries
  • unexplained infertility
  • no endometriosis

You may not qualify if:

  • poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Marwa Ba Tarahony

    Faculty of Medicine, Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Ba Tarahony

CONTACT

01008160037marwatarahony9@gmail.com

Kareem Ib Shaheen

CONTACT

01210966045

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eygpt Minia

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 4, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

September 4, 2020

Record last verified: 2020-08