NCT03402620

Brief Summary

infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

January 11, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

January 11, 2018

Last Update Submit

June 3, 2018

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

  • number of retrieved oocytes

    The number of oocyte retrived at ovum pickup

    34 hours after HCG triggering

Study Arms (2)

four ampoules group

ACTIVE COMPARATOR

gonadotropin starting dose is 4 ampoules daily

Drug: Gonadotropins

six ampoules group

ACTIVE COMPARATOR

gonadotropin starting dose is 6 ampoules daily

Drug: Gonadotropins

Interventions

GonadotropinsDRUG

Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

four ampoules groupsix ampoules group

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:
  • Age \>40 years or other cause of poor function.
  • AFC\<2-5 in both ovaries or AMH \< 0.5-1.1 ng/dl 2)
  • History of poor response with conventional stimulation protocol

You may not qualify if:

  • Uterine factor.
  • Severe male factor.
  • Endometriosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Gonadotropins

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ahmed Maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

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
professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

January 11, 2018

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

EG(1)